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A phase III clinical trial comparing the combination of capecitabine and oxaliplatin (XELOX) versus the combination of fluorouracil (5FU)/leucovorin (LV) and oxaliplatin (FOLFOX) as an adjuvant therapy in patients with operated colorectal cancer of stages B2 (high risk) and C (according to Duke’s)

ABSTRACT: Interventions: (XELOX) Xeloda: 1000 mg/m2 twice daily [by mouth (p.o.), morning and evening within 30 min of last meal], days 1 to 14 Oxaliplatin: 130 mg/m2 by 2-hour intravenous (IV) infusion, day 1 The treatment will commence in 4-6 weeks after surgery. Repeat every 21 days for 8 cycles Primary outcome(s): To compare the 3-year DFS (disease free survival) between the two group therapies [Xeloda and Oxaliplatin (XELOX) versus 5-FU/Leucovorin and Oxaliplatin (FOLFOX)] in patients with colorectal cancer of stage B2 (high risk) and C, according to Dukes[Disease-free survival will be assessed in each patient by history and physical examination at each cycle and by history, physical examination, serum tumor markers [Carcinoembryonic Antigen (CEA), Carbohydrate Antigen 19-9 (CA19-9)], computed tomography of the abdomen and pelvis and chest x-rays every 4 months and endoscopy every 1 year during follow-up. The final outcome will be assessed 3 years after the enrollment of the last patient at the study.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

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

PROVIDER: 2455895 | 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.

Dataset Information

A phase III clinical trial comparing the combination of capecitabine and oxaliplatin (XELOX) versus the combination of fluorouracil (5FU)/leucovorin (LV) and oxaliplatin (FOLFOX) as an adjuvant therapy in patients with operated colorectal cancer of stages B2 (high risk) and C (according to Duke’s)

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