Protocols Approved by Health Canada CTSU Information for Canadian Sites    Canada Approval Information RTOG STUDY NO. DRUG NAME DRUG NO. DATE APPROVED BY TPD TPD FORMS 0630 ---------- ---------- No Drug therapy- no submission required None Required 0627 (Amend 2) Dasatinib ---------- 11/01/2007 Clinical Trial Site Info. Form Qualified Investigator Undertaking Form Research Ethics Board Attestation No Objection Letter Appendix I 0618 ---------- ---------- No Drug therapy- no submission required None Required 0617 Paclitaxel/Carboplatin ---------- 11/07/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Form Research Ethics Board Attestation No Objection Letter 0615 (Amend 2) Cisplatin and Bevacizumab ---------- 12/12/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Form Research Ethics Board Attestation No Objection Letter 0614 Memantine ---------- 5/2/08 Clinical Trial Site Info. Form Qualified Investigator Undertaking Form Research Ethics Board Attestation No Objection Letter 0611 ---------- ---------- No drug therapy - no submission required None required 0534 Zoladex/Flutamide/Casodex 1/22/08 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0529 (Amend 2) 5-Fluorouracil and Mitomycin C 12/07/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0526 ----------- ----------- No Drug therapy- no submission required None Required 0525 (Amend 3) Temodar 2/12/08 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0524 (Amend 3) Trastuzumab/Taxol BGTD 2/21/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0522 (Amend 2) Erbitux, Cisplatin 03/21/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter * FDG NOL Submission to RTOG 0521 (Amend 3) Eulexin Casodex Taxotere 8/3/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Drug Request Form No Objection Letter Drug Accountability Form 0518 (Amend 3) Zometa 10/03/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter Appendix I 0517 (Amend 3) Zometa 11/26/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter Appendix I 0515 ---------- ---------- Radiation Therapy - no submission required None required * FDG NOL Submission to RTOG 0514 ---------- ---------- Radiation Therapy - no submission required None required 0513 Gadolinium, Temozolomide NCI Supplied 4/5/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Appendix 1 No Objection Letter 0438 ---------- ---------- Radiation Therapy - no submission required None required 0435 (Amend 1) Kepivance 02274221 10/05/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Appendix 1 No Objection Letter 0433 ---------- ---------- Contact NCIC for study information (Click here) 0424 (Amend 2) Temodar Drug supplied by NCI 7/7/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0420 (Closed) Temodar Camptosar Drug supplied by NCI02231622 09/27/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Appendix 1 No Objection Letter 0418 (Amend_2) Cisplatin 07/11/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0417 (Amend 1) Avastin Platinol 8/1/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0415 ---------- ---------- No drug therapy None required 0413 ---------- ---------- NSABP is the lead group 0412 (Amend 3) Cisplatin Pegfilgrastim Docetaxel 02126613 02249790 02177080, 02177099 3/30/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Drug Shipment Form No Objection Letter Drug Accountability Form 0411 (Amend 4) (Closed) Capecitabine Gemcitabine Bevacizumab 02238454, 02238453, 02230308, 02230309 Drug supplied by NCI 07/13/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Appendix 1 No Objection Letter 0330 (Amend 3) Thalidomide Drug supplied by NCI 11/8/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0324 (Amend 5) (Closed) Cetuximab, Paclitaxel, Carboplatin No DIN 02231605, 00788759 10/12/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements No Objection Letter 0321 ---------- ---------- Radiation Therapy - no submission required None required 0320 (Amend 4) Temodar/Erlotinib 02241093, 02241095, 02241094, 02241096 Investigational Drug 06/14/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Appendix I No Objection Letter 0319 (Closed) ---------- ---------- Radiation Therapy - no submission required None required 0315 (Amend 5) (Closed) Sandostatin 02239325 12/29/2005 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements No Objection letter 0312 ---------- ---------- Radiation Therapy - no submission required None required 0247 (Amend 6) 5-FU (5-Fluorouracil) Leucovorin Irinotecan Capecitabine Oxaliplatin 02063921, 02087316, 02231622, 02238454, 02238453 No Din 06/13/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter Drug Accountability Form 0246 (Amend 2) (Closed) Cisplatin Taxol (Paclitaxal) 5-FU (5-Fluorouracil) Neupogen (Filgrastim) 02126613, 02231605, 02182742, 02063921, 00012882 01968017 6/14/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0244 ---------- ---------- Radiation Therapy - no submission required None required 0241 (Rev. 5) (Closed) Comptosar (Irinotecan Hydrochloride) Cisplatin Neupogen (Filgrastim) 02231622 02126613 01968017 9/2/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0239 (Amend 3 & 4) Cisplatin Etoposide (VePesid) 00012882 02063794 11/22/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements No Objection Letter 0236 ---------- ---------- Radiation Therapy - no submission required None required 0235 ---------- Standard Drugs - Exempt None required * FDG NOL Submission to RTOG 0234 (Amend 5) 09/28/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0233 (Amend 4) Cisplatin Taxol (Paclitaxal) 5-FU (5-Fluorouracil) Gemzar (Gemcitabine) 02126613, 02231605, 02244372, 02016796, 02182742, 02230308 06/27/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0232 ---------- ---------- Radiation Therapy - no submission required None required 0229 (Amend 4) Paclitaxel Carboplatin 02161168, 02241927, 02241093, 02241095, 02241094, 02241096 7/5/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0227 (Amend 5) Rituxan Methotrexate Temodar 06/26/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0225 (Amend 5) (Closed) 5-FU (5-Fluorouracil) Cisplatin 02063921, 02182742, 00012882, 02126613 7/15/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0215 (Amend 3) (Closed) Viagra (Sildenafil) 02239767 10/4/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0214 ---------- ---------- Radiation Therapy - no submission required None required 0213 (Rev. 3) (Closed) Celebrex 02239942 7/2/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0212 ---------- ---------- Radiation Therapy - no submission required None required 0211 (Amend 7) (Closed) Iressa Investigational Drug 8/3/05 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 0132 (Amend 9) Gleevec ® 09/17/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements No Objection Letter 0131 (Rev. 1) (Closed) Temozolomide (Temodar) (02241093 thru 96) 2/6/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation H-0129 (Closed) ---------- ---------- Standard Drugs - no submission required None required 0128(Closed) Celebrex 02239942 10/21/02 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 0127 Selenium ---------- Grandfathered in by Health Canada None required 0126 ---------- ---------- Radiation Therapy - no submission required None required 0124 (Rev.3) (Closed) Cisplatin Taxol (Paclitaxal) Neupogen (Filgrastim) 02126613, 02231605, 01968017 2/3/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 0123 (Amend 3) Captopril 02238557, 02242788, 02238554, 02238450 06/19/06 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements No Objection Letter 0122 (Rev. 1) (Closed) Juven Supplement N/A 7/23/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 0118 (Rev. 4) (Closed) Thalidomide (Thalomid) Investigational Drug 1/19/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation L-0117 (Amend 5 & 6) Paraplatin (Carboplatin) Taxol (Paclitaxal) 00788759 02231605 01/03/2006 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements No Objection Letter 0116 (Rev 5 & 6) Amifostine 02218054 8/23/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter G-0114 (Rev 3) (Closed) Cisplatin Taxol (Paclitaxal) 02126613, 02231605 10/6/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 0113 (Rev. 5) (Closed) Cisplatin Taxol (Paclitaxal) 5-FU (5-Fluorouracil) Neupogen (Filgrastim) 02126613, 02231605, 02182742, 01968017 9/11/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation BR-0023 (Closed) BCNU (BiCNU) 00297763 2/24/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation H-0022 (Closed) ---------- ---------- Standard Drugs - no submission required None required PA-0020 (Closed) Cisplatin Taxol (Paclitaxal) R115777 02126613, 02231605 Investigational Drug 1/30/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 0017 (Rev. 4) (Closed) Gemcitabine, Paclitaxel, Carboplatin 02230308, 02231605, 00788759 10/30/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation P-0014 (Rev. 1) (Closed) Eulexin (Flutamide) 02239045 6/29/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter BR-0013 (Closed) Blenoxane 00258485 7/16/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 0012 (Rev. 1) (Closed) Comptosar (Irinotecan Hydrochloride) 02231622 10/28/02 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation P-0011 (Rev. 2) (Closed) Eulexin (Flutamide) 02239045 3/19/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 9915 (Closed) ---------- ---------- Standard Drugs - no submission required None required 9911 (Rev. 3) (Closed) Cisplatin Taxol (Paclitaxal) Neupogen (Filgrastim) 02126613, 02231605, 01968017 1/28/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 9910 (Closed) ---------- ---------- Health Canada granted Amnesty None required 9909(Closed) ---------- ---------- Titan Declined to open to Canadians No 9905 (Closed) Cisplatin Taxol (Paclitaxal) Neupogen (Filgrastim) 02126613, 02231605, 01968017 2/20/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 9904 (Closed) 5-FU (5-Fluorouracil) Cisplatin Taxol (Paclitaxal) 02063921, 02182742, 00012882, 02126613, 02231605 2/24/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 9903 (Rev. 4) (Closed) Eprex (Epoetin alfa) ---------- 9/23/02 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 9902 (Closed) Eulexin (Flutamide) Zoladex (Goserelin) Lupron (Leuprolide) Casodex (Bicalutamide) Emcyt (Estramustine) Etoposide (VePesid) Taxol (Paclitaxol) 02239045, 02225905, 020249325, 00836273, 02230248, 02239833, 02184478, 02063794, 00616192, 02016796 5/14/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Tissue/Blood Consent Health Canada Requirements No Objection Letter 9813 (Amend 8) Temodol (Temozolomide) BCNU (BiCNU) 02241093 thru 96 00297763 9/10/07 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation No Objection Letter 9811 (Rev. 5) (Closed) 5-FU (5-Fluorouracil) Cisplatin Mitomycin 02063921, 02182742, 00012882, 02126613, 02230451, 02230450, 00587710, 00381799, 00060410, 02230729, 02237745 12/9/03 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation Health Canada Requirements 9804 (Rev. 4) Nolvadex-D (Tamoxifen) 02048485 & 02048477 5/5/04 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation 9803 (Closed) BCNU (BiCNU) 00297763 Radiation Study Exempt None required 9601 (Closed) Casodex (Bicalutamide) No DIN Number 11/21/02 Clinical Trial Site Info. Form Qualified Investigator Undertaking Research Ethics Board Attestation