8/25/11:  See attached letter from KCCOP's IRB Coordinator regarding our new contact phone number on all consent forms.

Brain/CNS

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

Glioma

RTOG 0929:  Protocol Summary | Consent Form

GLIOMA, any high-grade (Phase I), glioblastoma or gliosarcoma (Phase II), recurrent; ABT-888 + Temozolomide

Meningioma

RTOG 0539:  Protocol Summary | Consent Form       

MENINGIOMA, WHO Grade I, II, or III, new dx or recur, any resection extent; IMRT for high-risk group (See RT credentialing requirements in protocol.)

Mets

RTOG 0933:  Protocol Summary | Consent Form       

METS, >5mm from either hippocampus, non-hematopoietic malig (except SC lung or germ cell); Eval of WBRT w/Hippocampal Avoidance using IMRT (See RT & Neurocognitive Function Testing requirements in protocol.)

CTSU N0574:  Protocol Summary | Consent Form      

METS, 1-3 from any extra-cerebral site, able to be treated w/gamma knife or linear accel-base radiosurgery; Radiosurgery +/- Whole Brain RT (See RT & Neurocognitive Function Testing requirements in protocol.)

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Breast

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

Stage 0

NSABP B-39:  Protocol Summary | Consent Form

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

RTOG 1005:  Protocol Summary | Consent Form   

(Neo-)Adj., Selected Stgs 0-II, resected by lumpectomy & whole breast RT, no regional nodal RT planned; Accelerated Whole Breast RT + Hypofractionation + Concurrent Boost vs Standard Whole Breast RT + Sequential Boost (Sites need approval - check RT requirements in protocol.)

Stage I

CTSU NCIC MA.32:  Protocol Summary | Consent Form

(Neo-)Adj., T1-3, N0-3, M0, invasive, >4 wks since surgery &/or chemo + SN bx &/or full axillary LN dissect; Metformin vs placebo

RTOG 1005:  Protocol Summary | Consent Form   

(Neo-)Adj., Selected Stgs 0-II, resected by lumpectomy & whole breast RT, no regional nodal RT planned; Accelerated Whole Breast RT + Hypofractionation + Concurrent Boost vs Standard Whole Breast RT + Sequential Boost (Sites need approval - check RT requirements in protocol.)

SWOG S1007:  Protocol Summary | Step 1 Consent Form | Step 2 Consent Form

Adj., N1-3, M0, ER+ &/or PgR+, HER-2 neg w/recur score <25, invasive; randomized trial of Standard Endocrine Therapy +/- Chemo

NSABP B-47:  Protocol Summary | Consent Form

Adj., T1-3, Node+ or Hi-Risk Node(-), prim tumor HER2-Low, post-mastectomy/lumpectomy + eval of nodal status; Chemo Alone (Docetaxel + Cyclophosphamide or Doxorubicin + Cyclophosphamide → Weekly Paclitaxel) vs Chemo (same regimens) + Trastuzumab

NSABP B-39:  Protocol Summary | Consent Form

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

CTSU NCIC MA.32:  Protocol Summary | Consent Form

(Neo-)Adj., T1-3, N0-3, M0, invasive, >4 wks since surgery &/or chemo + SN bx &/or full axillary LN dissect; Metformin vs placebo

RTOG 1005:  Protocol Summary | Consent Form   

(Neo-)Adj., Selected Stgs 0-II, resected by lumpectomy & whole breast RT, no regional nodal RT planned; Accelerated Whole Breast RT + Hypofractionation + Concurrent Boost vs Standard Whole Breast RT + Sequential Boost (Sites need approval - check RT requirements in protocol.)

SWOG S1007:  Protocol Summary | Step 1 Consent Form | Step 2 Consent Form

Adj., N1-3, M0, ER+ &/or PgR+, HER-2 neg w/recur score <25, invasive; randomized trial of Standard Endocrine Therapy +/- Chemo

CALGB 40603:  Protocol Summary | Consent Form

Neoadj., Stg II-III, Hormone-Receptor Poor/HER2-, resectable; Carboplatin +/- Bevacizumab + weekly Paclitaxel → Dose-Dense AC

SWOG S0800:  Protocol Summary | Consent Form

Neo-Adj., Inflammatory or Loc Adv (Stgs IIB or IIIA-C), HER2(-) & known receptor status; Nab-Paclitaxel +/- Bevacizumab, preceded by or followed by q2wk Doxorubicin + Cyclophosphamide + Pegfilgrastim

NSABP B-47:  Protocol Summary | Consent Form

Adj., T1-3, Node+ or Hi-Risk Node(-), prim tumor HER2-Low, post-mastectomy/lumpectomy + eval of nodal status; Chemo Alone (Docetaxel + Cyclophosphamide or Doxorubicin + Cyclophosphamide → Weekly Paclitaxel) vs Chemo (same regimens) + Trastuzumab

NSABP B-39:  Protocol Summary | Consent Form

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

CTSU NCIC MA.32:  Protocol Summary | Consent Form

(Neo-)Adj., T1-3, N0-3, M0, invasive, >4 wks since surgery &/or chemo + SN bx &/or full axillary LN dissect; Metformin vs placebo

CALGB 40603:  Protocol Summary | Consent Form

Neoadj., Stg II-III, Hormone-Receptor Poor/HER2-, resectable; Carboplatin +/- Bevacizumab + weekly Paclitaxel → Dose-Dense AC

SWOG S1007:  Protocol Summary | Step 1 Consent Form | Step 2 Consent Form

Adj., N1-3, M0, ER+ &/or PgR+, HER-2 neg w/recur score <25, invasive; randomized trial of Standard Endocrine Therapy +/- Chemo

SWOG S0800:  Protocol Summary | Consent Form

Neo-Adj., Inflammatory or Loc Adv (Stgs IIB or IIIA-C), HER2(-) & known receptor status; Nab-Paclitaxel +/- Bevacizumab, preceded by or followed by q2wk Doxorubicin + Cyclophosphamide + Pegfilgrastim

NSABP B-47:  Protocol Summary | Consent Form

Adj., T1-3, Node+ or Hi-Risk Node(-), prim tumor HER2-Low, post-mastectomy/lumpectomy + eval of nodal status; Chemo Alone (Docetaxel + Cyclophosphamide or Doxorubicin + Cyclophosphamide → Weekly Paclitaxel) vs Chemo (same regimens) + Trastuzumab

Stage IV

CTSU E2108:  Protocol Summary | Consent Form

Intact primary (not recurrent) & >1 distant met; Optimal systemic therapy → (if CR, PR, SD) Continued systemic therapy vs Early local therapy (surgery + RT)

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SWOG S0702:  Protocol Summary | Consent Form

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

MDA 2007-0914A:  Protocol Summary | Consent Form  

Any cancer dx, starting new anthracycline-based chemo course (not limited to 1^st-line therapy); Eval of Biomarkers for Cardiotoxicity (Equipment & training is provided; each site must become certified to use Biosite – see protocol.)

URCC 08106:  Protocol Summary | Consent Form  

Any cancer dx (no leukemia), M0, chemo naive, planning to start chemo lasting >6 wks (tx cycles can be 2, 3, or 4 wks); Effects of exercise on cancer-related fatigue (Staff administering exercise intervention must be trained & approved by URCC.)

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

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

URCC 10055:  Protocol Summary | Consent Form

BREAST (invasive, Stg I-IIIC) or LYMPHOMA (interm- or high-grade), no prior chemo & scheduled to begin chemo; Asmt of Cognitive Function (Requires control subject.  Training in cognitive testing & blood handling procedures is required.)

SWOG S0927:  Protocol Summary | Consent Form

Stgs I-III, M0, post-modified radical mastectomy or breast-sparing surg, post-menopausal, ER+ &/or PgR+, taking 3^rd gen Aromatase Inhibitor; Omega 3 fatty acid vs placebo for musculoskeletal pain/stiffness

CTSU CCCWF 97609:  Protocol Summary | Consent Form

Stgs 0-IIIA (incl DCIS), new dx, post-lumpectomy, -quadrantectomy, or –mastectomy, planned adjuv RT to whole breast +/- regional LNs; Eval of genomics & exposures on Radiosensitivity

Cancer Control:  GI

NSABP P-5:  Protocol Summary | Consent Form

COLON, resected adenocarcinoma, Stg I or II, post-adjuv therapy; Rosuvastatin vs placebo polyp prevention trial

CTSU N08CB:  Protocol Summary | Consent Form

COLON or RECTUM, adenocarcinoma, post-curative resection, Stg II-III or IV (completely resected & no residual tumor), scheduled for Oxaliplatin-based adjuv chemo; IV Ca/Mg in 2 versions (vs placebo) to prevent sensory neurotoxicity

GOG-0237:  Protocol Summary | Consent Form

CERVICAL, Atypical glandular cells; Analysis of CA-IX, p16, proliferative markers, & HPV in diagnosing cervical lesions

GOG-0259:  Protocol Summary | Consent Form

OVARIAN, FALLOPIAN TUBE, or PRIM PERITONEAL, Recur or Persis, active disease or tx not required; Nurse-Delivered WRITE Symptoms vs Self-Directed WRITE Symptoms vs Care as Usual

GOG-0267:  Protocol Summary | Consent Form

OVARIAN, FALLOPIAN TUBE or PERITONEAL, persis or recur, platinum-resistant; Eval of QOL & care needs

Cancer Control:  Lung

RTOG 1012:  Protocol Summary | Consent Form

SC or NSC, M0, being treated w/definitive or adjuv chemo + RT, >5cm of esophagus in 60Gy isodose volume; Eval of standard supportive care vs Manuka honey (liquid vs lozenge) to reduce chemoradiation-induced esophagitis pain (See RT credentialing requirements in protocol.  Training & computer required for PRO-CTCAE.)

Cancer Control:  Lymphoma

URCC 10055:  Protocol Summary | Consent Form

BREAST (invasive, Stg I-IIIC) or LYMPHOMA (interm- or high-grade), no prior chemo & scheduled to begin chemo; Asmt of Cognitive Function (Requires control subject.  Training in cognitive testing & blood handling procedures is required.)

Colon

CALGB 80702:  Protocol Summary | Consent Form

COLON, Stg III, resected; 6 vs 12 txs of adjuv FOLFOX + Celecoxib/placebo

Esophagus

RTOG 1010:  Protocol Summary | Consent Form

ESOPHAGUS, adenocarcinoma (involving mid, distal, EG junction, or stomach), Stg T1N1-2 or T2-3N0-2; MANDATORY tissue submission for HER2 (if HER2+) → RT + Paclitaxel + Carbo +/- Trastuzumab → Surgery +/- Maintenance Trastuzumab (See RT credentialing requirements in protocol.)

RTOG 0436:  Protocol Summary | Consent Form

ESOPHAGUS or GE JUNCTION, squamous or adenocarcinoma, T1N1M0, T2-4 Any N M0, or Any T, Any N, M1a; RT + Paclitaxel + Cisplatin +/- Cetuximab (See RT credentialing requirements in protocol.)

CALGB 80802:  Protocol Summary | Consent Form

HEPATOCELLULAR, locally adv or mets, no prior allografts; Doxorubicin +/- Sorafenib

CTSU E1208:  Protocol Summary | Consent Form

HEPATOCELLULAR (limited to liver), unresectable; Chemoemobilization +/- Sorafenib

Pancreas

CALGB 80701:  Protocol Summary | Consent Form

PANCREAS, Neuroendocrine, Adv or Mets; Everolimus +/- Bevacizumab

Other

RTOG 0436:  Protocol Summary | Consent Form

ESOPHAGUS or GE JUNCTION, squamous or adenocarcinoma, T1N1M0, T2-4 Any N M0, or Any T, Any N, M1a; RT + Paclitaxel + Cisplatin +/- Cetuximab (See RT credentialing requirements in protocol.)

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RTOG 0534:  Protocol Summary | Consent Form

PROSTATE, Adenocarcinoma, T3N0/Nx or T2N0/Nx +/- positive surg margin, rising PSA post-radical prostatectomy; Prostate Bed RT (PBRT) vs PBRT + Neoadjuv & Concurrent short-term androgen depriv (NC-STAD) vs PBRT + NC-STAD + Pelvic Lymph Node RT (See RT & neurocognitive function credentialing requirements in protocol.)

RTOG 0815:  Protocol Summary | Consent Form

PROSTATE, Adenocarcinoma, Interm risk (Gleason 7, PSA>10 & <20, &/or Clin Stg T2b-T2c); Dose-Escal RT +/- Short-Term Androgen Deprivation (See RT credentialing requirements in protocol.)

RTOG 0534:  Protocol Summary | Consent Form

PROSTATE, Adenocarcinoma, T3N0/Nx or T2N0/Nx +/- positive surg margin, rising PSA post-radical prostatectomy; Prostate Bed RT (PBRT) vs PBRT + Neoadjuv & Concurrent short-term androgen depriv (NC-STAD) vs PBRT + NC-STAD + Pelvic Lymph Node RT (See RT & neurocognitive function credentialing requirements in protocol.)

SWOG S0931:  Protocol Summary | Consent Form  

RENAL, Interm High Risk or Very High Risk, no distant mets, post radical nephrectomy or partial nephrectomy; Everolimus/placebo x 54 wks

CALGB 90601:  Protocol Summary | Consent Form

URINARY TRACT (Renal Pelvis, Ureter, Bladder, Prostate, or Urethra), Transitional cell, Mets or Locally Adv; Gemcitabine + Cisplatin + Bevacizumab/placebo

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GOG-0249:  Protocol Summary | Consent Form 

ENDOMETRIAL, Post-Hyst/BSO & peritoneal cytol, Stg I-IIA (high-interm risk), IIB (occult, any histol, +/- risk factors), I-IIB (occult, serous or clear, +/- risk factors); Pelvic RT vs Vaginal Cuff Brachy + Paclitaxel & Carboplatin (See RT credentialing requirements in protocol.)

GOG-0258:  Protocol Summary | Consent Form

ENDOMETRIAL, Stgs I or II (selected) & all Stg III or IVA, post-hysterectomy & BSO; Cisplatin + volume-directed RT → Carboplatin + Paclitaxel vs Carboplatin + Paclitaxel alone (See RT credentialing requirements in protocol – for investigator & facility.)

GOG-0261:  Protocol Summary | Consent Form

UTERINE or OVARIAN, Carcinosarcoma (mixed mesodermal), persistent or recur, Stgs I-IV, newly dxd & chemo naive; Paclitaxel + Carboplatin vs Ifosfamide + Paclitaxel

GOG-0213:  Protocol Summary | Consent Form

OVARIAN (Epithelial), PERITONEAL (Prim), or FALLOPIAN, recurrent, platinum-sensitive; Secondary Cytoreduction vs no surg  ! Carbo + Paclitaxel +/- Bevacizumab  ! Maintenance Bevacizumab

GOG-0212:  Protocol Summary | Consent Form

OVARIAN or FALLOPIAN TUBE (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 (PARTICIPATION LIMITED)

GOG-0261:  Protocol Summary | Consent Form

UTERINE or OVARIAN, Carcinosarcoma (mixed mesodermal), persistent or recur, Stgs I-IV, newly dxd & chemo naive; Paclitaxel + Carboplatin vs Ifosfamide + Paclitaxel

CTSU E1305:  Protocol Summary | Consent Form       

Squamous, any prim site (including unknown), recur or mets; Platinum-doublet +/- Bevacizumab

RTOG 0920:  Protocol Summary | Consent Form       

ORAL CAVITY, OROPHARYNX, or LARYNX, squamous & its variants, T1 N1-2 or T2-4a N0-2 M0 w/no distant mets, post-total resection w/curative intent; EGFR (& HPV - oropharynx pts only) analyses  ! IMRT (or optional IGRT) +/- Cetuximab (See RT credentialing requirements in protocol.)

RTOG 1016:  Protocol Summary | Consent Form  

OROPHARYNX, p16 positive, T1-2 N2a-N3 or T3-4, any N; p16 analysis  ! Accelerated IMRT + high dose DDP vs Accelerated IMRT + Cetuximab (See IMRT & IGRT credentialing requirements in protocol.  Register w/CASI system & set up CRA  account b/f 1^st regist.)

Acute

SWOG S0703:  Protocol Summary | Consent Form         

AML (non-M3), no prior tx, age >60; Azacitidine + Gemtuzumab Ozogamicin as Induction & Post-Remission therapy

SWOG S0535:  Protocol Summary | Consent Form         

APL, High-Risk, prev untreated, pre-tx cytogenetics mandatory; (Induction) ATRA+Gemtuzumab Ozogamicin+Arsenic Trioxide ! (Consolidation) Arsenic Trioxide (Cy 1 & 2) ! ATRA+Daunomycin (Cy 3 & 4) ! Gemtuzumab Ozogamicin (Cy 5 & 6)

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  (Each site must have 2 trained counselors available for counseling Lenalidomide pts.)

CALGB 10404:  Protocol Summary | Consent Form       

CLL (B-cell), symptomatic & active intermediate or high-risk Rai staging, no prior tx; Randomized study of 4 Fludarabine/Antibody Combinations (Each site must have 2 trained counselors available for counseling Lenalidomide pts.)

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 140503:  Protocol Summary | Consent Form

NSC, peripheral nodule <2cm, N0, M0; Lobectomy vs Sublobar Resection (If pt is randomized to Lobectomy arm & surgeon plans to use VATS procedure, surgeon must be credentialed per protocol.)

CTSU E1505:  Protocol Summary | Consent Form

NSC, Stgs IB (>4cm) - IIIA, completely resected; 1 of 4 chemo regimens +/- Bevacizumab

RTOG 0813:  Protocol Summary | Consent Form

NSC, Stg I, centrally located, medically inoperable; Eval of Stereotactic Lung RT (See RT credentialing requirements in protocol.)

CTSU E1505:  Protocol Summary | Consent Form

NSC, Stgs IB (>4cm) - IIIA, completely resected; 1 of 4 chemo regimens +/- Bevacizumab

CTSU E1505:  Protocol Summary | Consent Form

NSC, Stgs IB (>4cm) - IIIA, completely resected; 1 of 4 chemo regimens +/- Bevacizumab

RTOG 1106:  Protocol Summary | Consent Form

NSC, Stgs IIIA-B, non-resectable, FDG-avid (max SUV >4.0); Screening Plan (baseline FDG-PET/CT) → randomized Concurrent Chemoradiotherapy (+/- adaptations made at during-RT FDG-PET/CT) → FDG-PET CT (all pts) → Consolidative Chemo (Sites must complete requirements for 1) 3D or IMRT, 2) IGRT, 3) FDG-PET/CT, & 4) send materials for RT rapid review.)

CALGB 30607:  Protocol Summary | Consent Form  

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

RTOG 1106:  Protocol Summary | Consent Form

NSC, Stgs IIIA-B, non-resectable, FDG-avid (max SUV >4.0); Screening Plan (baseline FDG-PET/CT) → randomized Concurrent Chemoradiotherapy (+/- adaptations made at during-RT FDG-PET/CT) → FDG-PET CT (all pts) → Consolidative Chemo (Sites must complete requirements for 1) 3D or IMRT, 2) IGRT, 3) FDG-PET/CT, & 4) send materials for RT rapid review.)

CTSU E5508:  Protocol Summary | Consent Form        

NSC, Stg IV & selected Stg IIIB, non-squamous; Carbo + Paclitaxel + Bevacizumab à maintenance Bevacizumab vs Pemetrexed vs Bevacizumab/Pemetrexed

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; Sunitinib vs placebo

SWOG S0819:  Protocol Summary | Consent Form

NSC, Stg IV, new dx or recur; Carboplatin/Paclitaxel vs Carboplatin/Paclitaxel/Bevacizumab +/- Concurrent Cetuximab

CTSU E5508:  Protocol Summary | Consent Form        

NSC, Stg IV & selected Stg IIIB, non-squamous; Carbo + Paclitaxel + Bevacizumab à maintenance Bevacizumab vs Pemetrexed vs Bevacizumab/Pemetrexed

Small Cell

CALGB 30610:  Protocol Summary | Consent Form

SC (max 1 hemithorax w/regional LN mets), no prior RT, chemo, or complete resection; Comparison of 3 thoracic RT regimens + Cisplatin & Etoposide

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Lymphoma

Hodgkin's

SWOG S0816:  Protocol Summary | Consent Form  

Hodgkin’s, Stgs III-IV, prev untreated; ABVD ! Full Body FDG-PET ! 4 ABVD cycles or 6 BEACOPP cycles (based on FDG-PET outcome), Central Review of all FDG-PET scans required

Non Hodgkin's

CALGB 50904:  Protocol Summary | Consent Form  

NH, follicular, WHO Grade 1, 2, 3a, no prior tx; Ofatumumab + Bendamustine +/- Bortezomib (Sites must be credentialed for FDG-PET/CT imaging – see protocol.)

SWOG S1108:  Protocol Summary | Consent Form  

NH, Perip T-cell, relapsed/refractory, >1 prior systemic therapy; Eval of Aurora Kinase A Inhibitor MLN8237

SWOG S1001:  Protocol Summary | Consent Form  

NH, Diffuse Large B-Cell, Stg I or II; R-CHOP → R-CHOP (if PET-) or IFRT → Zevalin (if PET+) (Sites must complete requirements for Zevalin administration b/f registering 1^st pt, meet 3D-CRT or IMRT requirements, & submit materials for RT rapid review.)

SWOG S0806:  Protocol Summary | Consent Form  

NH, Diffuse Large B-Cell, Stg II (bulky) or Stgs III-IV, new dx; Vorinostat + Rituximab-CHOP

Melanoma

CTSU E1609:  Protocol Summary | Consent Form

Stgs IIIB, IIIC, or IV, cutaneous or unknown prim (w/cutaneous, subcutaneous, nodal, or lung mets), completely surgically resected; Ipilimumab Anti-CTLA4 (Highdose vs Lowdose) vs High-Dose Interferon α-2b  (Investigator Ipilimumab training/exam required b/f registering 1^st pt – see protocol.)

CTSU E2607:  Protocol Summary | Consent Form

Mets or Unresec (mucosal, accrual, vulvovaginal), c-KIT+; Eval of Dasatinib

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