Protocol and Consent Forms

Modified:  May 16, 2008

NOTE:  Limited funding may be available to offset costs on certain protocols.  Contact KCCOP for more information.

Also, see Cancer Control section for symptom management/prevention trials.

CALGB C10001:  Protocol Summary | Donor Consent | Recipient Consent

ALL, Ph+, complete remission after tx on CALGB 10102; Sequential Chemo+Gleevec+Transplantation (QARC approval required for TBI)

CALGB 100104:  Protocol Summary | Consent Form 

MM, Durie-Salmon Stg >1, stable or responsive to >2 mos of any induction therapy; Autologous

PBSCT → Maintenance CC-5013/placebo

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Brain/CNS

Also, see Cancer Control section for symptom management/prevention trials.

Glioma

RTOG 0627:  Protocol Summary |  Consent Form

GLIOMA, glioblastoma multiforme or gliosarcoma, recur, prior RT & Temozolomide required; Eval of Dasatinib

RTOG 0525:  Protocol Summary |  Consent Form

GLIOMA, glioblastoma (includes gliosarcoma), supratentorial component, new dx; Conventional Adjuv Temozolomide vs Dose-Intens Temozolomide

MDA 2004-0662:  Protocol Summary | Consent Form

GLIOMA, glioblastoma multiforme, post-op or post-bx RT required; Temozolomide Alone vs Temozolomide in combination w/permutations of Thalidomide, Isotretinoin, &/or Celecoxib

Other

RTOG 0227:  Protocol Summary |  Consent Form

CNS Lymphoma (Prim, B-cell, CD20+); Pre-RT Chemo (Methotrexate + Rituximab + Temozolomide) & Post-RT Temozolomide

Breast

Also, see Cancer Control section for symptom management/prevention trials.

Stage 0

CTSU PACCT-1:  Protocol Summary | Consent Form

Adj., Stgs 0, I , Selected II, Hormone+, N0, Candidate for cytotoxic + hormonal therapy; Trial of Individualized Options for Tx (TAILORx Trial)

NSABP B-39:  Protocol Summary | Consent Form

Adj., Stg. 0, I, II; Conventional Whole Breast RT vs Partial Breast RT (Multi-Catheter, Mammosite, or 3D-CRT) (Sites need approval - check RT requirements in protocol.)

Stage I

CTSU PACCT-1:  Protocol Summary | Consent Form

Adj., Stgs 0, I , Selected II, Hormone+, N0, Candidate for cytotoxic + hormonal therapy; Trial of Individualized Options for Tx (TAILORx Trial)

NSABP B-42: Protocol Summary | Randomization Consent | Optional Registration Program Consent

Adj. or Neoadj., Stg I, II, IIIA (rcvd. neoadjuv chemo) or prim tumor T1-3 & ipsilateral nodes pN0-pN3b (rcvd. adjuv chemo), ER+ &/or PgR+, post-meno, completed 5 yrs Arom Inhib or Tamox + AI; Letrozole vs placebo for prolonging survival

CTSU NCIC MA.27:  Protocol Summary | Consent Form  

Adj., T1-3, Nx, N0-2 (N3 if >10 involved axillary nodes), M0, ER+ &/or PgR+, Post-meno; Exemestane vs Anastrozole

CALGB 40101: Protocol Summary | Consent Form 

Adj., T1‑4, N0-3, M0; Cyclophosphamide + Doxorubicin vs Paclitaxel

SWOG S0307: Protocol Summary | Consent Form 

Adj., Stg I, II, III, Zoledronic Acid vs Clodronate vs Ibandronate (+ standard adjuv tx)

SWOG S0221:  Protocol Summary | Consent Form

Adj., Stg I, II, III, Node+ or Hi-Risk Node -, male pts allowed; Continuous Schedule Doxorubicin+Cyclophosphade+GCSF vs q2wk Doxorubicin+Cyclophosphade, both → Taxol (q2wks vs weekly x 12 wks)

NSABP B-39:  Protocol Summary | Consent Form

Adj., Stg. 0, I, II; Conventional Whole Breast RT vs Partial Breast RT (Multi-Catheter, Mammosite, or 3D-CRT) (Sites need approval - check RT requirements in protocol.)

NSABP B-36:  Protocol Summary | Consent Form

Adj., T1-3N0M0; 5FU + Epirubicin + Cyclophosphamide vs Adriamycin + Cyclophosphamide

SWOG JMA.17R:  Protocol Summary | Consent Form

 <2 yrs post-completion of aromatase inhibitor therapy, disease-free; Letrozole vs placebo x 5 yrs

CTSU MA.27B:  Protocol Summary | Consent Form  

MANDATORY Companion to MA.27; Bone Mineral Density study (Stratum A closed to accrual.)

CTSU MA.27D:  Protocol Summary | Consent Form  

MANDATORY Companion to MA.27; Breast Density, Plasma Hormone Chgs & Breast Ca Recur

Stage II

CTSU PACCT-1:  Protocol Summary | Consent Form

Adj., Stgs 0, I , Selected II, Hormone+, N0, Candidate for cytotoxic + hormonal therapy; Trial of Individualized Options for Tx (TAILORx Trial)

NSABP B-42: Protocol Summary | Randomization Consent | Optional Registration Program Consent

Adj. or Neoadj., Stg I, II, IIIA (rcvd. neoadjuv chemo) or prim tumor T1-3 & ipsilateral nodes pN0-pN3b (rcvd. adjuv chemo), ER+ &/or PgR+, post-meno, completed 5 yrs Arom Inhib or Tamox + AI; Letrozole vs placebo for prolonging survival

CTSU NCIC MA.27:  Protocol Summary | Consent Form  

Adj., T1-3, Nx, N0-2 (N3 if >10 involved axillary nodes), M0, ER+ &/or PgR+, Post-meno; Exemestane vs Anastrozole

NSABP B-40:  Protocol Summary | Consent Form  

Neoadj., T2-3, Nx/N0-cN2a, M0, HER2-; Capecitabine + Docetaxel or Gemcitabine + Docetaxel prior to AC +/- Bevacizumab (6 regimens) + Correlative Science Studies → Surgery → Post-Op Bevacizumab (pre-op Bevacizumab regimens only)

CTSU ACOSOG Z1031: Protocol Summary | Consent Form  

Neoadj., T2-4c, any N, M0, Post-meno, ER+; 16-18 wks Exemestane vs Letrozole vs Anastrozole

SWOG S0307: Protocol Summary | Consent Form 

Adj., Stg I, II, III, Zoledronic Acid vs Clodronate vs Ibandronate (+ standard adjuv tx)

SWOG S0221:  Protocol Summary | Consent Form

Adj., Stg I, II, III, Node+ or Hi-Risk Node -, male pts allowed; Continuous Schedule Doxorubicin+Cyclophosphade+GCSF vs q2wk Doxorubicin+Cyclophosphade, both → Taxol (q2wks vs weekly x 12 wks)

NSABP B-39:  Protocol Summary | Consent Form

Adj., Stg. 0, I, II; Conventional Whole Breast RT vs Partial Breast RT (Multi-Catheter, Mammosite, or 3D-CRT) (Sites need approval - check RT requirements in protocol.)

NSABP B-36:  Protocol Summary | Consent Form

Adj., T1-3N0M0; 5FU + Epirubicin + Cyclophosphamide vs Adriamycin + Cyclophosphamide

CALGB 40101: Protocol Summary | Consent Form 

Adj., T1‑4, N0-3, M0; Cyclophosphamide + Doxorubicin vs Paclitaxel

SWOG JMA.17R:  Protocol Summary | Consent Form

  <2 yrs post-completion of aromatase inhibitor therapy, disease-free; Letrozole vs placebo x 5 yrs

CTSU MA.27B:  Protocol Summary | Consent Form  

MANDATORY Companion to MA.27; Bone Mineral Density study (Stratum A closed to accrual.)

CTSU MA.27D:  Protocol Summary | Consent Form  

MANDATORY Companion to MA.27; Breast Density, Plasma Hormone Chgs & Breast Ca Recur

Stage III

CALGB 40101:  Protocol Summary | Consent Form

Adj., T1‑4, N0-3, M0; Cyclophosphamide + Doxorubicin vs Paclitaxel

CTSU ACOSOG Z1031: Protocol Summary | Consent Form  

Neoadj., T2-4c, any N, M0, Post-meno, ER+; 16-18 wks Exemestane vs Letrozole vs Anastrozole

NSABP B-42: Protocol Summary | Randomization Consent | Optional Registration Program Consent

Adj. or Neoadj., Stg I, II, IIIA (rcvd. neoadjuv chemo) or prim tumor T1-3 & ipsilateral nodes pN0-pN3b (rcvd. adjuv chemo), ER+ &/or PgR+, post-meno, completed 5 yrs Arom Inhib or Tamox + AI; Letrozole vs placebo for prolonging survival

CTSU NCIC MA.27:  Protocol Summary | Consent Form  

Adj., T1-3, Nx, N0-2 (N3 if >10 involved axillary nodes), M0, ER+ &/or PgR+, Post-meno; Exemestane vs Anastrozole

SWOG S0307: Protocol Summary | Consent Form 

Adj., Stg I, II, III, Zoledronic Acid vs Clodronate vs Ibandronate (+ standard adjuv tx)

SWOG S0221:  Protocol Summary | Consent Form

Adj., Stg I, II, III, Node+ or Hi-Risk Node -, male pts allowed; Continuous Schedule Doxorubicin+Cyclophosphade+GCSF vs q2wk Doxorubicin+Cyclophosphade, both → Taxol (q2wks vs weekly x 12 wks)

NSABP B-40:  Protocol Summary | Consent Form  

Neoadj., T2-3, Nx/N0-cN2a, M0, HER2-; Capecitabine + Docetaxel or Gemcitabine + Docetaxel prior to AC +/- Bevacizumab (6 regimens) + Correlative Science Studies → Surgery → Post-Op Bevacizumab (pre-op Bevacizumab regimens only)

CTSU MA.27B:  Protocol Summary | Consent Form  

MANDATORY Companion to MA.27; Bone Mineral Density study (Stratum A closed to accrual.)

CTSU MA.27D:  Protocol Summary | Consent Form  

MANDATORY Companion to MA.27; Breast Density, Plasma Hormone Chgs & Breast Ca Recur

Recurrent/Metastatic

SWOG S0226:  Protocol Summary | Consent Form

Mets or Prog; Post-Menopausal; Anastrozole +/- Fulvestrant as First-Line Therapy

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Cancer Control:  Any Site

URCC U3905:  Protocol Summary | Consent Form

Standard tx completed 2-12 mos; Eval of Yoga for persistent sleep disturbance

RTOG 0433:  Protocol Summary | Consent Form

Bone Mets; Single vs Multiple Fractions for Re-Irradiation

URCC U1902:  Protocol Summary | Consent Form

Any cancer dx, <1 prior chemo cycle & to receive >3 more chemo cycles; Ginger vs placebo for nausea caused by chemo

URCC U1701:  Protocol Summary | Consent Form

Any cancer dx, must receive chemo at least next 4 wks; Buspirone vs placebo to control dyspnea

Cancer Control:  Breast

RTOG 0517:  Protocol Summary | Consent Form

BONE METS (from Breast, Lung, Prostate), must complete EBRT <14 days pre-regist, chemo or hormonal therapy allowed; Zometa+Vit D+Ca +/- Single Dose Sr-89 or Sm-153

MDA 2005-0328:  Protocol Summary | Consent Form 

BREAST or COLORECTAL, mets, planning to receive Capecitabine; Celecoxib for prevention of hand/foot syndrome

URCC U1105:  Protocol Summary | Consent Form

No prior chemo, planned Doxorubicin- or Epirubicin-containing regimen w/o concurrent RT or IFN; 4 Double-blind regimens for preventing delayed nausea

CALGB 70301:  Protocol Summary | Consent Form

Companion Study to CALGB 40101; QOL, Employment & Informal Care Cost Analysis

Cancer Control:  GI

MDA 2005-0328:  Protocol Summary | Consent Form 

BREAST or COLORECTAL, mets, planning to receive Capecitabine; Celecoxib for prevention of hand/foot syndrome

NSABP LTS-01:  Protocol Summary | Consent Form

COLON or RECTAL, Pt reported outcomes in long-term survivors of C-05, C-06, C-07, & R-02

Cancer Control:  GU

RTOG 0517:  Protocol Summary | Consent Form

BONE METS (from Breast, Lung, Prostate), must complete EBRT <14 days pre-regist, chemo or hormonal therapy allowed; Zometa+Vit D+Ca +/- Single Dose Sr-89 or Sm-153

RTOG 0518:  Protocol Summary | Consent Form

PROSTATE, Stgs I-IV (M0), Gleason/PSA dep, receiving concurrent RT & Long-Term LHRG Agonists; Zometa/placebo for Osteoporosis/Fx Prevention

SWOG S0437:  Protocol Summary | Consent Form | Consent Form (Next-of-Kin)

PROSTATE, Long-Term followup for PCPT participants diagnosed w/Prostate Ca

Cancer Control:  Gyn

GOG 0215:  Protocol Summary | Consent Form

Incr genetic risk of ovarian ca & electing risk-reducing surg (minimum removal of both ovaries); Zoledronic Acid vs Observ on Bone Mineral Density in Lumbar Spine

Cancer Control:  Lung

RTOG 0517:  Protocol Summary | Consent Form

BONE METS (from Breast, Lung, Prostate), must complete EBRT <14 days pre-regist, chemo or hormonal therapy allowed; Zometa+Vit D+Ca +/- Single Dose Sr-89 or Sm-153

SWOG E5597:  Protocol Summary | Consent Form

NSC, Resected Stage IA or IB; Selenium Supplementation as Chemoprevention

SWOG S0424:  Protocol Summary | Consent Form

Molecular Epidemiology Study; NSCLC in Smoking & Non-Smoking Men/Women

Cancer Control:  Lymphoma

SWOG 8819:  Protocol Summary  (no consent form)

Path Companion to SWOG-coordinated protocols for prev untreated, NH lymphoma

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Also, see Cancer Control section for symptom management/prevention trials.

Colorectal

NSABP C-10:  Protocol Summary | Consent Form

COLON, Stg IV (Unresec) & synchronous asymptomatic prim tumor; 5FU + Leucovorin + Oxaliplatin + Bevacizumab

CALGB 80405:  Protocol Summary | Consent Form

COLORECTAL, Adenocarcinoma (Adv or Mets), Untreated; Either FOLFOX or FOLFIRI with either Bevacizumab or Cetuximab or w/combined Bevacizumab & Cetuximab

CTSU N0147: Protocol Summary | Consent Form

COLORECTAL, Stg III, Post-Curative Resec; Oxal + 5FU /Leuc +/- Cetuximab

Esophagus

CALGB 80403:  Protocol Summary | Consent Form

ESOPHAGUS or GE Junction, Mets; ECF-C vs IC-C vs FOLFOX-C

SWOG S0356:  Protocol Summary | Consent Form

ESOPHAGUS or GE Junction, Stg II-III; Pre-Op Oxal+5FU & RT → Surgery → Post-op Oxal+5FU (QARC Benchmark info required per site)

Rectal

NSABP R-04:  Protocol Summary | Consent Form

RECTAL, Stgs II-III, operable invasive adenocarcinoma; Pre-op RT + Capecitabine +/- Oxal vs Pre-op RT + CI 5-FU +/- Oxal (RNALater specimens required)

Stomach

CALGB 80101:  Protocol Summary | Consent Form

STOMACH or GE Junction, Post-Resection, Stg IB (if N1 or tumor exten beyond muscularis propria), II, IIIA-B, IV (w/M0); Eval of 2 Chemoradiation Regimens (Rapid Review required - check RT requirements)

Other

CALGB 80403:  Protocol Summary | Consent Form

ESOPHAGUS or GE Junction, Mets; ECF-C vs IC-C vs FOLFOX-C

SWOG S0356:  Protocol Summary | Consent Form

ESOPHAGUS or GE Junction, Stg II-III; Pre-Op Oxal+5FU & RT → Surgery → Post-op Oxal+5FU (QARC Benchmark info required per site)

CALGB 80101:  Protocol Summary | Consent Form

STOMACH or GE Junction, Post-Resection, Stg IB (if N1 or tumor exten beyond muscularis propria), II, IIIA-B, IV (w/M0); Eval of 2 Chemoradiation Regimens (Rapid Review required - check RT requirements)

 TOP

Also, see Cancer Control section for symptom management/prevention trials.

Prostate:  Stage I

RTOG 0521:  Protocol Summary | Consent Form

PROSTATE, Localized Stgs I, II, III & select Stg IV (T4), High-Risk; Androgen Suppr + 3DCRT/IMRT +/- Docetaxel & Prednisone chemo (Sites need approval - check RT requirements in protocol.)

RTOG 0526:  Protocol Summary | Consent Form

PROSTATE, T1-T2c, Gleason 2-6 & PSA<20ng/ML or Gleason 7 & PSA<10ng/mL, local recur post-EBRT; eval of Transperineal US-Guided Brachytherapy (Sites need approval - see RT requirements in protocol.)

Prostate:  Stage II

RTOG 0415:  Protocol Summary | Consent Form

PROSTATE, T1-2c, favorable risk; Hypofractionated vs Conventionally Fractionated 3D CRT/IMRT (Sites need approval - see RT requirements in protocol.)

RTOG 0521:  Protocol Summary | Consent Form

PROSTATE, Localized Stgs I, II, III & select Stg IV (T4), High-Risk; Androgen Suppr + 3DCRT/IMRT +/- Docetaxel & Prednisone chemo (Sites need approval - check RT requirements in protocol.)

RTOG 0526:  Protocol Summary | Consent Form

PROSTATE, T1-T2c, Gleason 2-6 & PSA<20ng/ML or Gleason 7 & PSA<10ng/mL, local recur post-EBRT; eval of Transperineal US-Guided Brachytherapy (Sites need approval - see RT requirements in protocol.)

RTOG 0232:  Protocol Summary | Consent Form

PROSTATE, T1c-2b, Nx/N0, M0; Ext Beam RT+Transperineal Interstitial Permanent Brachytherapy vs Brachytherapy alone (Sites need approval - check RT requirements in protocol.)

RTOG 0612:  Protocol Summary | Consent Form

PROSTATE, Markers of RT Outcome for Pts Enrolled on RTOG 0232

RTOG 0126:  Protocol Summary | Consent Form | Tissue Consent Form

PROSTATE, T1b-2b, Gleason 2-6 & PSA ≥10 & <20 or Gleason 7 & PSA <15; High- vs Standard-Dose 3D-CRT/IMRT

Prostate:  Stage III

RTOG 0521:  Protocol Summary | Consent Form

PROSTATE, Localized Stgs I, II, III & select Stg IV (T4), High-Risk; Androgen Suppr + 3DCRT/IMRT +/- Docetaxel & Prednisone chemo (Sites need approval - check RT requirements in protocol.)

Prostate:  Stage IV

SWOG S0421:  Protocol Summary | Consent Form

PROSTATE, Adenocarcinoma, Any T & N, M1b + bone mets, hormone refrac; Docetaxel + Atrasentan vs Docetaxel + placebo

RTOG 0521:  Protocol Summary | Consent Form

PROSTATE, Localized Stgs I, II, III & select Stg IV (T4), High-Risk; Androgen Suppr + 3DCRT/IMRT +/- Docetaxel & Prednisone chemo (Sites need approval - check RT requirements in protocol.)

CALGB 90202:  Protocol Summary | Consent Form

PROSTATE, Adenocarcinoma, >1 bone met; Early vs Standard Zoledronic Acid to prevent skeletal-related events

Prostate:  Recurrent / Persistent / Progressive

ID 00-156:  Protocol Summary | Consent Form

PROSTATE, Adenocarcinoma, androgen-indep, rising PSA; Induction Chemo → Consolid Therapy +/- Strontium-89

Renal

CTSU E2805:  Protocol Summary | Consent Form

RENAL, Resectable, no distant mets; Double-blind adjuv Sunitinib vs Sorafenib vs placebo

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GYN

Also, see Cancer Control section for symptom management/prevention trials.

Cervical:  Stage I

GOG 0219:  Protocol Summary | Consent Form

CERVICAL, Stgs I-B2, II-A (>4cm), II-B, III-B, IV-A, primary, untreated, squamous, adenocarcinoma, or adenosquamous; Weekly Cisp+RT vs Cisp+Tirapazamine+RT

RTOG 0418:  Protocol Summary | Consent Form

 CERVICAL, Hysterectomy <7 wks pre-study entry, requiring chemoradiation; Pelvic IMRT +/- Chemo

RTOG 0417:  Protocol Summary | Consent Form             

CERVICAL, Stgs IIB-IIIB or IB-IIA (if bx-proven pelvic node mets &/or tumor >5cm), untreated; Bevacizumab + Definitive RT + Cisplatin (Compliance review for GYN brachytherapy is required.)

 

Cervical:  Stage II

GOG 0219:  Protocol Summary | Consent Form

CERVICAL, Stgs I-B2, II-A (>4cm), II-B, III-B, IV-A, primary, untreated, squamous, adenocarcinoma, or adenosquamous; Weekly Cisp+RT vs Cisp+Tirapazamine+RT

RTOG 0418:  Protocol Summary | Consent Form

CERVICAL, Hysterectomy <7 wks pre-study entry, requiring chemoradiation; Pelvic IMRT +/- Chemo

RTOG 0417:  Protocol Summary | Consent Form             

CERVICAL, Stgs IIB-IIIB or IB-IIA (if bx-proven pelvic node mets &/or tumor >5cm), untreated; Bevacizumab + Definitive RT + Cisplatin (Compliance review for GYN brachytherapy is required.)

Cervical:  Stage III

GOG 0219:  Protocol Summary | Consent Form

CERVICAL, Stgs I-B2, II-A (>4cm), II-B, III-B, IV-A, primary, untreated, squamous, adenocarcinoma, or adenosquamous; Weekly Cisp+RT vs Cisp+Tirapazamine+RT

RTOG 0418:  Protocol Summary | Consent Form

CERVICAL, Hysterectomy <7 wks pre-study entry, requiring chemoradiation; Pelvic IMRT +/- Chemo

RTOG 0417:  Protocol Summary | Consent Form             

CERVICAL, Stgs IIB-IIIB or IB-IIA (if bx-proven pelvic node mets &/or tumor >5cm), untreated; Bevacizumab + Definitive RT + Cisplatin (Compliance review for GYN brachytherapy is required.)

GOG 0209:  Protocol Summary | Consent Form

ENDOMETRIAL, Stgs III-IV or Recur, no prior chemo; Doxo/Cisp/Taxol + G-CSF vs Carbo/Taxol

GOG 0209:  Protocol Summary | Consent Form

ENDOMETRIAL, Stgs III-IV or Recur, no prior chemo; Doxo/Cisp/Taxol + G-CSF vs Carbo/Taxol

GOG 0209:  Protocol Summary | Consent Form

ENDOMETRIAL, Stgs III-IV or Recur, no prior chemo; Doxo/Cisp/Taxol + G-CSF vs Carbo/Taxol

GOG 0229F:  Protocol Summary | Consent Form

ENDOMETRIAL, Recur or Persis, 1 prior chemotherapeutic regimen for endometrial cancer required; Eval

of VEGF-Trap

Ovarian:  Stage III

GOG 0218:  Protocol Summary | Consent Form

OVARIAN (Epith) or PERITONEAL (Prim), Stg III (any gross [macroscopic or palpable] residual disease) or IV, Prev Untreated; 3 Arms: Each w/Carbo & Paclitaxel, in addition to Placebo vs Concurrent Bevacizumab → Placebo vs Concurrent & Extended Bevacizumab

GOG 0212:  Protocol Summary | Consent Form

OVARIAN (Adv, Epith) or PERITONEAL (Prim), CR after Prim Platinum/Taxane chemo; Maint Chemo (12 monthly cycles of Paclitaxel or CT-2103) vs No Tx until relapse

GOG 0235:  Protocol Summary | Consent Form

OVARIAN (Invasive, Epith), PERITONEAL (Prim), or FALLOPIAN, Stgs III or IV, undergoing prim chemo; Longitudinal Study of YKL-40

Ovarian:  Stage IV

GOG 0218:  Protocol Summary | Consent Form

OVARIAN (Epith) or PERITONEAL (Prim), Stg III (any gross [macroscopic or palpable] residual disease) or IV, Prev Untreated; 3 Arms: Each w/Carbo & Paclitaxel, in addition to Placebo vs Concurrent Bevacizumab → Placebo vs Concurrent & Extended Bevacizumab

GOG 0212:  Protocol Summary | Consent Form

OVARIAN (Adv, Epith) or PERITONEAL (Prim), CR after Prim Platinum/Taxane chemo; Maint Chemo (12 monthly cycles of Paclitaxel or CT-2103) vs No Tx until relapse

GOG 0235:  Protocol Summary | Consent Form

OVARIAN (Invasive, Epith), PERITONEAL (Prim), or FALLOPIAN, Stgs III or IV, undergoing prim chemo; Longitudinal Study of YKL-40

Vulvar

GOG 0205:  Protocol Summary | Consent Form

VULVAR, Locally Adv, Prev Untreated, Squamous; RT + Weekly Cisplatin

Other

GOG 0235:  Protocol Summary | Consent Form

OVARIAN (Invasive, Epith), PERITONEAL (Prim), or FALLOPIAN, Stgs III or IV, undergoing prim chemo; Longitudinal Study of YKL-40

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Head & Neck

Also, see Cancer Control section for symptom management/prevention trials.

CTSU E1302:  Protocol Summary | Consent Form | Consent Form (if opting to continue tx w/ZD1839)

Squamous, Mets or Locally Recur or PS 2, no nasopharynx WHO 2 & 3; Docetaxel + ZD1839 or placebo

RTOG 0522:  Protocol Summary | Consent Form

OROPHARYNX, HYPOPHARYNX, LARYNX, Squamous, Selected Stgs III & IV; Concurrent Accelerated RT + Cisp +/- Cetuximab → Surg for selected pts (Sites need approval - check RT requirements in protocol.)

RTOG 0514:  Protocol Summary | Consent Form

Head & Neck Cancer Tissue/Specimen Bank

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Also, see Cancer Control section for symptom management/prevention trials.

Acute

CALGB C10001: Protocol Summary | Donor Consent | Recipient Consent

ALL, Ph+, complete remission after tx on CALGB 10102; Sequential Chemo+Gleevec+Transplantation (QARC approval required for TBI)

SWOG S0333:  Protocol Summary | Consent Form

ALL, Non-L3, New Dx, age <65; double Induction Chemo → Consolid Chemo → Maint Chemo

CTSU E2902:  Protocol Summary | Consent Form           

AML, >2^nd remission or remission after prim induction failure or >age 60 in 1^st remission; R115777 (Zarnestra) vs Observ

SWOG S0106:  Protocol Summary | Consent Form

AML (non-M3), DeNovo, age <61, no prior tx; Daunomycin + Ara-C +/- Mylotarg Induction → Ara-C Consolid → Post-Consolid Mylotarg or No Additional Therapy

Chronic

CALGB 10404:  Protocol Summary | Consent Form           

CLL (B-cell), symptomatic & active intermediate or high-risk Rai staging, no prior tx; Randomized study of 3 Fludarabine/Antibody combinations

CALGB 10501:  Protocol Summary | Consent Form                 

CLL (B-cell), asymptomatic & untreated, <6 mos from initial flow cytometric confirmation, IgV_H unmutated subset; Early Tx vs Observation w/Later Tx (both using Rituximab & Fludarabine)

SWOG S0325:  Protocol Summary | Consent Form

CML, in chronic phase, no prior tx; Imatinib vs Dasatinib

Ancillary

SWOG 9007:  Protocol Summary | Consent Form

MANDATORY Cytometry Companion to all Leukemia tx protocols

SWOG S9910:  Protocol Summary | Consent Form

Ancillary; specimen submission to Centralized Reference Lab & Tissue Repository

CALGB 8461:  Protocol Summary | Consent Form

Cytogenetics study for prev untreated AML, ALL, MDS

CALGB 9665:  Protocol Summary | Consent Form

Tissue Bank for prev untreated leukemia pts (acute or chronic) & MDS

CALGB 9760:  Protocol Summary | Consent Form

Multidrug Resistance studies for prev untreated AML & ALL

CALGB 9862:  Protocol Summary | Consent Form

Molecular Genetic study for ALL; MANDATORY for CALGB 19802 & its successors

 TOP

Also, see Cancer Control section for symptom management/prevention trials.

NSC:  Stage II

RTOG 0235:  Protocol Summary | Consent Form

NSC, Stgs IIB or III, inoperable, no diffuse bronchoalveolar; PET pre- & post-Definitive Chemoradiation

NSC:  Stage IIIA - Unresectable

RTOG 0235:  Protocol Summary | Consent Form

NSC, Stgs IIB or III, inoperable, no diffuse bronchoalveolar; PET pre- & post-Definitive Chemoradiation

NSC:  Stage IIIB

RTOG 0235:  Protocol Summary | Consent Form

NSC, Stgs IIB or III, inoperable, no diffuse bronchoalveolar; PET pre- & post-Definitive Chemoradiation

NSC:  Stage IV

RTOG 0320:  Protocol Summary | Consent Form

NSC, 1-3 Brain Mets; Whole Brain RT+Stereotactic Radiosurgery +/- Temozolomide or Erlotinib

Ancillary

SWOG S9925:  Protocol Summary   (no consent form)

Ancillary, Specimen Repository Companion

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Lymphoma

Also, see Cancer Control section for symptom management/prevention trials.

Non-Hodgkin's:  Stage II

SWOG S0016:  Protocol Summary | Consent Form

NH, Bulky Stg II or III-IV, Prev Untreated, Follicular, CD20+; CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody

MDA 2004-0305:  Protocol Summary | Consent Form

NH, B-Cell (incl. diffuse large B-Cell), >Stg II, aggressive, age >61, prev untreated; Rituximab-CHOP + Pegylated Liposomal Doxorubicin

SWOG S0515:  Protocol Summary | Consent Form

NH, Bulky Stg II or III-IV diffuse large B-cell, prev untreated, CD20+, age >60; Standard Dose CHOP + Rituximab + Bevacizumab

Non-Hodgkin's:  Stage III

SWOG S0016:  Protocol Summary | Consent Form

NH, Bulky Stg II or III-IV, Prev Untreated, Follicular, CD20+; CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody

MDA 2004-0305:  Protocol Summary | Consent Form

NH, B-Cell (incl. diffuse large B-Cell), >Stg II, aggressive, age >61, prev untreated; Rituximab-CHOP + Pegylated Liposomal Doxorubicin

SWOG S0515:  Protocol Summary | Consent Form

NH, Bulky Stg II or III-IV diffuse large B-cell, prev untreated, CD20+, age >60; Standard Dose CHOP + Rituximab + Bevacizumab

CTSU E4402:  Protocol Summary | Consent Form

NH, Stg III-IV, Low Tumor Burden Indolent; Induc Rituximab → Rituximab (4 weekly doses vs Single dose q12wks)

Non-Hodgkin's:  Stage IV

SWOG S0016:  Protocol Summary | Consent Form

NH, Bulky Stg II or III-IV, Prev Untreated, Follicular, CD20+; CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody

MDA 2004-0305:  Protocol Summary | Consent Form

NH, B-Cell (incl. diffuse large B-Cell), >Stg II, aggressive, age >61, prev untreated; Rituximab-CHOP + Pegylated Liposomal Doxorubicin

SWOG S0515:  Protocol Summary | Consent Form

NH, Bulky Stg II or III-IV diffuse large B-cell, prev untreated, CD20+, age >60; Standard Dose CHOP + Rituximab + Bevacizumab

CTSU E4402:  Protocol Summary | Consent Form

NH, Stg III-IV, Low Tumor Burden Indolent; Induc Rituximab → Rituximab (4 weekly doses vs Single dose q12wks)

Non-Hodgkin's:  Relapsed / Refractory

CALGB 50401:  Protocol Summary | Consent Form 

NH, Not Rituximab-refractory, Grade 1, 2, or 3a, Follicular; Lenalidomide vs Rituximab + Lenalidomide

SWOG S0520:  Protocol Summary | Consent Form

B-Cell (diffuse large; high-grade Burkitt or Burkitt-like; prim mediastinal), Relapsed or Refrac, aggressive, not suitable for stem cell transp if 1^st relapse; Eval of PXD101

Mantle Cell

SWOG S0601:  Protocol Summary | Consent Form         

Mantle Cell, Stg III-IV, Bulky Stg II, Prev Untreated; Combination Rituximab-CHOP + Bortezomib induction therapy → Bortezomib maintenance

Other

CALGB 50202:  Protocol Summary | Consent Form

CNS, Prim, no NH, prev untreated; Intensive Chemo & Immunotherapy

Ancillary

SWOG 8947:  Protocol Summary | Consent Form

Serum Companion to SWOG-coord protocols for prev untreated, NH lymphoma

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Myeloma

Also, see Cancer Control section for symptom management/prevention trials.

SWOG S0120:  Protocol Summary | Consent Form

MGUS, asymptomatic Myeloma, or Solitary Plasmacytoma, not requiring tx; Observational Biologic Study (BM aspir & Perip Blood)

CALGB 100104:  Protocol Summary | Consent Form 

MM, Durie-Salmon Stg >1, stable or responsive to >2 mos of any induction therapy; Autologous

PBSCT → Maintenance CC-5013/placebo

SWOG S0434:  Protocol Summary | Consent Form

MM, Relapsed or Resistant; Eval of BAY 43-9006

SWOG S0309:  Protocol Summary

Ancillary, Specimen Repository Protocol

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