Protocol and Consent Forms

Last Updated:  July 1, 2009

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 (Only SLH is currently approved for BMT.  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  (Only SLH is currently approved for BMT.)

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Brain/CNS

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

Glioma

RTOG 0424:  Protocol Summary | Consent Form     

ASTROCYTOMA, OLIGODENDROGLIOMA, or OLIGOASTROCYTOMA, High Risk, Low Grade; Temozolomide + RT ! Temozolomide x 12 wks

RTOG 0825:  Protocol Summary | Consent Form     

GLIOMA, Glioblastoma or Gliosarcoma (Grade IV), newly dx; Central Path Review, Conventional Concurrent Chemoradiation + Adjuv Temozolomide + Bevacizumab/placebo (double-blind) (see RT & Neurocognitive Function Testing requirements in protocol)

RTOG 0627:  Protocol Summary | Consent Form     

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

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 (Investigator & RN must complete STEPS regist – contact KCCOP)

Other

CALGB 50202:  Protocol Summary | Consent Form

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

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

NSABP B-43:  Protocol Summary | Pre-Entry HER2 Test Consent Form | Consent Form    

Adj., Stg 0 (DCIS or mixed DCIS/LCIS), post-lumpectomy, HER2+; RT +/- concurrent Trastuzumab

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)

IBCSG 25-02:  Protocol Summary | Consent Form  | Addendum Consent Form (pts randomized prior to 1/1/08)

Adj., T1-3, N0-2, M0, Pre-meno, ER+ &/or PgR+; Triptorelin + TMX x 5 yr vs Triptorelin + Exemestane x 5 yrs (both arms +/- adjuv chemo)

IBCSG 24-02:  Protocol Summary | Consent Form

Adj., Premenopausal, Stgs I, II, & + int mamm nodes by SN (not enlarged), ER &/or PgR+; Prim Surg ! TMX vs Ovarian Func Suppr + TMX vs Ovarian Func Suppr + Exemestane (Currently open only at SLH.  Other sites – contact KCCOP to begin regulatory process.)

NSABP B-44-I:  Protocol Summary | Pre-Randomization (HER2) Consent | Treatment Consent Form

Adj., Stgs I-III, HER2(+), Node(+) or High Risk Node(-); Taxol + Carboplatin + Trastuzumab ! Trastuzumab +/- Bevacizumab (Industry trial - participation limited to 2 institutions – only SLH currently approved.)

NSABP B-42: Protocol Summary | Consent Form

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

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.)

CTSU N063D:  Protocol Summary | Consent Form

(Neo-)Adj., known ER/PgR or ER, HER2+, must have rcvd >4 cycles  of anthracycline-based (neo-)adj chemo;

Eval of sequences of Lapatinib &/or Trastuzumab (randomized arms).  Effective 3/15/09, Design 1 is closed.

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)

IBCSG 25-02:  Protocol Summary | Consent Form  | Addendum Consent Form (pts randomized prior to 1/1/08)

Adj., T1-3, N0-2, M0, Pre-meno, ER+ &/or PgR+; Triptorelin + TMX x 5 yr vs Triptorelin + Exemestane x 5 yrs (both arms +/- adjuv chemo)

IBCSG 24-02:  Protocol Summary | Consent Form

Adj., Premenopausal, Stgs I, II, & + int mamm nodes by SN (not enlarged), ER &/or PgR+; Prim Surg ! TMX vs Ovarian Func Suppr + TMX vs Ovarian Func Suppr + Exemestane (Currently open only at SLH.  Other sites – contact KCCOP to begin regulatory process.)

NSABP B-44-I:  Protocol Summary | Pre-Randomization (HER2) Consent | Treatment Consent Form

Adj., Stgs I-III, HER2(+), Node(+) or High Risk Node(-); Taxol + Carboplatin + Trastuzumab ! Trastuzumab +/- Bevacizumab (Industry trial - participation limited to 2 institutions – only SLH currently approved.)

CTSU N063D:  Protocol Summary | Consent Form

(Neo-)Adj., known ER/PgR or ER, HER2+, must have rcvd >4 cycles  of anthracycline-based (neo-)adj chemo;

Eval of sequences of Lapatinib &/or Trastuzumab (randomized arms).  Effective 3/15/09, Design 1 is closed.

ACOSOG Z1031:  Protocol Summary | Consent Form

                        Supplemental Sample Consent | Optional Genome Research Consent

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

NSABP B-41: Protocol Summary | Consent Form  

Neoadj., Stgs IIA-B & selected Stg IIIA, HER2+, palpable & operable; AC ! Taxol + Trastuzumab vs AC ! Taxol + Lapatinib vs AC ! Taxol + Trastuzumab + Lapatinib (all Arms followed by Surg & post-surg Trastuzumab, & required correlative studies for path CR)

NSABP B-42: Protocol Summary | Consent Form

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

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)

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.)

CALGB 40101: Protocol Summary | Consent Form 

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

Stage III

CALGB 40101:  Protocol Summary | Consent Form

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

NSABP B-44-I:  Protocol Summary | Pre-Randomization (HER2) Consent | Treatment Consent Form

Adj., Stgs I-III, HER2(+), Node(+) or High Risk Node(-); Taxol + Carboplatin + Trastuzumab ! Trastuzumab +/- Bevacizumab (Industry trial - participation limited to 2 institutions – only SLH currently approved.)

CTSU N063D:  Protocol Summary | Consent Form

(Neo-)Adj., known ER/PgR or ER, HER2+, must have rcvd >4 cycles  of anthracycline-based (neo-)adj chemo;

Eval of sequences of Lapatinib &/or Trastuzumab (randomized arms).  Effective 3/15/09, Design 1 is closed.

ACOSOG Z1031:  Protocol Summary | Consent Form

                        Supplemental Sample Consent | Optional Genome Research Consent

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

NSABP B-41: Protocol Summary | Consent Form  

Neoadj., Stgs IIA-B & selected Stg IIIA, HER2+, palpable & operable; AC ! Taxol + Trastuzumab vs AC ! Taxol + Lapatinib vs AC ! Taxol + Trastuzumab + Lapatinib (all Arms followed by Surg & post-surg Trastuzumab, & required correlative studies for path CR)

NSABP B-42: Protocol Summary | Consent Form

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

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)

CALGB 40502:  Protocol Summary | Consent Form           

Stg IIIB or IV, known HER-2/neu, ER, & PgR status; 1^st-line randomized trial of Paclitaxel vs

Nanoparticle Albumin-Bound Paclitaxel + Bevacizumab vs Ixabepilone + Bevacixumab (all given

weekly)

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)

Recurrent/Metastatic

CALGB 40502:  Protocol Summary | Consent Form           

Stg IIIB or IV, known HER-2/neu, ER, & PgR status; 1^st-line randomized trial of Paclitaxel vs

Nanoparticle Albumin-Bound Paclitaxel + Bevacizumab vs Ixabepilone + Bevacixumab (all given

weekly)

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

RTOG 0433:  Protocol Summary | Consent Form

Bone Mets; Single vs Multiple Fractions for Re-Irradiation

SWOG S0702:  Protocol Summary | Consent Form

Bone Mets from any site, plan to receive Zoledronic acid; Observational study of ONJ

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

URCC U1105:  Protocol Summary | Consent Form

No prior chemo, planned Cisplatin, Carboplatin, Oxaliplatin, 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:  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

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

CTSU N0147:  Protocol Summary | Consent Form

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

CALGB 80405:  Protocol Summary | Consent Form

COLORECTAL, Adenocarcinoma (Adv or Mets), Untreated, Wild type K-ras (determined pre-regist ); Either FOLFOX or FOLFIRI with either Bevacizumab or Cetuximab or w/combined Bevacizumab & Cetuximab

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)

RTOG 0822:  Protocol Summary | Consent Form                

RECTAL, T3-T4, N0-2, M0; Pre-op IMRT + Concurrent Capecitabine & Oxaliplatin ! Surgery ! Post-Op FOLFOX  (Sites need approval – check RT requirements in protocol)

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 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)

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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.)

Prostate:  Stage II

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 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

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

PROSTATE, Adenocarcinoma, Stg IV, Androgen-Indep; Induction Chemo ! Doxorubicin +/- single dose

Strontium-89

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

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

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

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

GOG-0248:  Protocol Summary | Consent Form                              

ENDOMETRIAL, Adv, Persis, or Recur; Weekly Temsirolimus vs Weekly Temsirolimus + alternating

Megestrol Acetate (x3wks) & Tamoxifen (x3wks)

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 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 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.

RTOG 0619:  Protocol Summary | Consent Form    

ORAL CAVITY, OROPHARYNX, LARYNX, HYPOPHARYNX (no lip, nasopharynx, sinuses), Squamous, Post-op Stg III-IV (pre-op stage I-IV); Chemoradiotherapy +/- Vandetanib (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 (Only SLH is currently approved for BMT.  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

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

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

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

CTSU E2905:  Protocol Summary | Consent Form 

MDS or non-proliferative CMML, Low- or Intermediate-1-risk, symptomatic anemia; Frequency of Major Erythroid

Response to Lenalidomide +/- Epoetin Alfa

Ancillary

SWOG 9007:  Protocol Summary | Consent Form

MANDATORY Cytometry Companion to all Leukemia tx protocols

Molecular Genetic study for prev untreated ALL; MANDATORY for CALGB tx trials

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

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

NSC:  Stage IIIA

RTOG 0617:  Protocol Summary | Consent Form

NSC, Stgs IIIA-B (Unresectable), M0; Stand Dose (60Gy) vs High-Dose (74Gy) Conformal RT + Concurrent & Consolidation Carbo/Taxol +/- Cetuximab (Sites need approval – check RT requirements in protocol)

NSC:  Stage IIIB

RTOG 0617:  Protocol Summary | Consent Form

NSC, Stgs IIIA-B (Unresectable), M0; Sted approval – check RT requirements in protocol)

CALGB 30607:  Protocol Summary | Consent Form  

NSC, Stg IIIB-IV, must have rcvd 4 cycles of platinum-based chemo +/- Bevacizumab & had no progression; Eval of Sunitinib vs placebo

NSC:  Stage IV

CALGB 30607:  Protocol Summary | Consent Form  

NSC, Stg IIIB-IV, must have rcvd 4 cycles of platinum-based chemo +/- Bevacizumab & had no progression; Eval of Sunitinib vs placebo

RTOG 0320:  Protocol Summary | Consent Form

NSC, 1-3 Brain Mets; Whole Brain RT+Stereotactic Radiosurgery +/- Temozolomide or Erlotinib (each treating facility must have an RTOG-approved Stereotactic RT Facility Questionnaire for this study)

NSC:  Advanced / Progressive

CTSU N0723:  Protocol Summary | Consent Form

NSC, Adv or Prog; Central Path Review & FISH pre-regist, Biomarker Validation of 2^nd line therapy (Erlotinib)

in pts randomized to Pemetrexed vs 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

CALGB 50401:  Protocol Summary | Consent Form 

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

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 (Only SLH is currently approved for BMT.)

SWOG S0309:  Protocol Summary

Ancillary, Specimen Repository Protocol

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Misc.

CTSU E1Y03:  Protocol Summary | Consent Form          

Master Protocol; Pharmacogenetic & Genomic Studies