Protocol and Consent Forms

Last Updated:  February 1, 2010

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

Brain/CNS

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

Glioma

CTSU N0577:  Protocol Summary | Consent Form  

ANAPLASTIC GLIOMA (oligodendroglioma, mixed, or astrocytoma), post-surgical dx, Co-deleted 1p/19q, Central Path Review required pre-regist; RT vs Temozolomide vs RT + concurrent & adjuv Temozolomide (see Neurocognitive Certification requirement in protocol)

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, & Pharmacist must complete STEPS regist – contact KCCOP)

Meningioma

RTOG 0539:  Protocol Summary | Consent Form       

MENINGIOMA, WHO Grade I, II, or III, new dx or recur, any resection extent; Observation for low-risk & RT for intermed- or high-risk groups (see RT credentialing requirements in protocol)

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)

IBCSG 25-02:  Protocol Summary | Consent Form 

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 - WILL RECEIVE FUNDS, NOT CREDITS.  PARTICIPATION LIMITED - ONLY SLH CURRENTLY APPROVED.)

CALGB 40101: Protocol Summary | Consent Form 

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

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.)

(Neo-)Adj., known ER/PgR or ER, HER2+, must have rcvd >4 cycles of anthracycline-based (neo-)adj chemo OR have plans for concurrent non-anthracycline platinum chemo; Eval of sequences of Lapatinib &/or Trastuzumab (randomized arms)

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 

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 - WILL RECEIVE FUNDS, NOT CREDITS.  PARTICIPATION LIMITED - ONLY SLH CURRENTLY APPROVED.)

Surg, T1-4, N1-2, M0; Eval of SLN & ALND following neo-adjuv therapy

(Neo-)Adj., known ER/PgR or ER, HER2+, must have rcvd >4 cycles of anthracycline-based (neo-)adj chemo OR have plans for concurrent non-anthracycline platinum chemo; Eval of sequences of Lapatinib &/or Trastuzumab (randomized arms)

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)

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) (INDUSTRY TRIAL - WILL RECEIVE FUNDS, NOT CREDITS.  PARTICIPATION LIMITED - ONLY SLH CURRENTLY APPROVED.)

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 ! Bx ! Continued AI therapy, chemo, or surg (depending on Ki67 score)

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 - WILL RECEIVE FUNDS, NOT CREDITS.  PARTICIPATION LIMITED - ONLY SLH CURRENTLY APPROVED.)

Surg, T1-4, N1-2, M0; Eval of SLN & ALND following neo-adjuv therapy

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)

(Neo-)Adj., known ER/PgR or ER, HER2+, must have rcvd >4 cycles of anthracycline-based (neo-)adj chemo OR have plans for concurrent non-anthracycline platinum chemo; Eval of sequences of Lapatinib &/or Trastuzumab (randomized arms)

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)

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) (INDUSTRY TRIAL - WILL RECEIVE FUNDS, NOT CREDITS.  PARTICIPATION LIMITED - ONLY SLH CURRENTLY APPROVED.)

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 ! Bx ! Continued AI therapy, chemo, or surg (depending on Ki67 score)

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)

 TOP

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

MDA 2007-0791:  Protocol Summary | Consent Form

Any site, self-reported pain (any cause), prescribed or using Morphine or Oxycodone SR; Oral Methadone vs switching between Morphine SR & Oxycodone SR (see protocol for Methadone prescriber training requirement)

Any cancer dx, 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

URCC 08106:  Protocol Summary | Consent Form  

Any cancer dx, M0, planning to start chemo lasting >6 wks (tx cycles must be 2 or 3 wks); Effects of exercise on cancer-related fatigue (staff administering exercise intervention must be trained & approved by URCC)

Cancer Control:  Breast

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

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

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 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

 TOP

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

Colorectal

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

Pancreas

SWOG S0727:  Protocol Summary | Consent Form                

PANCREAS, Stg IV, Unresec, adenocarcinoma; Gemcitabine + Erlotinib +/- IMC-A12 as 1^st line tx

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

 TOP

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

Prostate:  Stage II

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 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 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)

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

CALGB 90202:  Protocol Summary | Consent Form

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

Renal

CTSU E2804:  Protocol Summary | Consent Form  

RENAL, clear cell w/<25% any other histology, mets untreatable by RT or surg, prior nephrectomy (some exceptions); VEGF, RAF Kinase, & MTOR Comb. Targeted Therapy w/Bevacizumab, Sorafenib, & Temsirolimus

CTSU E2805:  Protocol Summary | Consent Form