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A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation in patients with simultaneous primary and metastatic rectal cancer

ABSTRACT: Interventions: Single arm study - Integrated preoperative radiotherapy and chemotherapy over 11 weeks. Treatment: drugs Oxaliplatin (given intravenously): day 1 of each of weeks 1, 6 and 11 100mg/m2 given; day 1 of each of weeks weeks 3 and 8, 85 mg/m2 given. Flurouracil: day 1 of each of weeks 1, 6 and 11 400mg/m2 bolus, given intravenously followed on day 1 by continuous infusion 2.4 g/m2, over 46 hours; on days of radiotherapy during both weeks 3-5 and weeks 8-10 - continuous infusion 200mg/m2/day over 96 hours Leucovorin (given intravenously): day 1 of each of weeks 1, 6 and 11 200mg/m2 given. Bevacizumab (given intravenously): day 1 of each of weeks 1, 3, 5, 7, 9 and 11 - 5mg/kg Treatment: Other Radiation Therapy: in both weeks 3-5 and weeks 8-10 25.2Gy in 14 fractions over 2 weeks and 4 days. A total of 50.4 Gy in 1.8 Gy per fraction is given. The first 45 Gy is given to the pelvic volume and the final 5.4 Gy is given to a boost volume. Primary outcome(s): Tolerability rate: the percentage of patients who are able to complete the planned treatment program and do not require a treatment break for toxicity.[End of the treatment program (11 weeks)] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Metastatic Rectal Cancer,Primary Rectal Cancer

PROVIDER: 2456506 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: ?1st Arm: Short course radiotherapy with 25 Gy in 5 fractions with concurrent chemotherapy regimen including Capecitabine 625mg/m2/bid for 5 days and Oxaliplatin 50mg/m2/day for 1 day then one cycle chemotherapy with XELOX regimen (Capecitabine 1000mg/m2/bid for 14 days and Oxaliplatin 130mg/m2/day for 1 day) 3 - 4 weeks after completion of radiotherapy then surgery at least 8 weeks after the radiotherapy last session. Intervention 2: 2nd Arm (Control): Long course radiotherapy with 50 Gy in 25 fractions with concurrent Capecitabine 825mg/m2/bid for 5 days each week then one cycle chemotherapy with XELOX regimen (Capecitabine 1000mg/m2/bid for 14 days and Oxaliplatin 130mg/m2/day for 1 day) 3 - 4 weeks after completion of radiotherapy then surgery at least 8 weeks after the radiotherapy last session.;Treatment - Drugs;Treatment - Drugs;?1st Arm: Short course radiotherapy with 25 Gy in 5 fractions with concurrent chemotherapy regimen including Capecitabine 625mg/m2/bid for 5 days and Oxaliplatin 50mg/m2/day for 1 day then one cycle chemotherapy with XELOX regimen (Capecitabine 1000mg/m2/bid for 14 days and Oxaliplatin 130mg/m2/day for 1 day) 3 - 4 weeks after completion of radiotherapy then surgery at least 8 weeks after the radiotherapy last session.;2nd Arm (Control): Long course radiotherapy with 50 Gy in 25 fractions with concurrent Capecitabine 825mg/m2/bid for 5 days each week then one cycle chemotherapy with XELOX regimen (Capecitabine 1000mg/m2/bid for 14 days and Oxaliplatin 130mg/m2/day for 1 day) 3 - 4 weeks after completion of radiotherapy then surgery at least 8 weeks after the radiotherapy last session. Primary outcome(s): Complications. Timepoint: At the Initiation of Radiotherapy up to one month after surgery. Method of measurement: Common terminology criteria for cancer related therapy adverse events. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.

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A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation in patients with simultaneous primary and metastatic rectal cancer

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