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Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.

ABSTRACT: Interventions: Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox). Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site. Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks. Primary outcome(s): Disease free survival, determined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause.[During treatment: prior to each treatment cycle. Patients on the 3 month treatment arm will be reviewed 4 weekly for the first twelve weeks after completion of chemotherapy. Clinical examination and Carcinoembryonic Antigen test will be performed at each visit. Follow-up: assessment will be at three monthly intervals until month 12 then 6 monthly until month 24 and annually thereafter.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

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

PROVIDER: 2454988 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Alternating oxaliplatin and irinotecan doublet treatment schedules. Arm A:Clinician’s choice doublet chemotherapy (standard chemotherapy) Arm B: Alternating schedule of 2 cycles of oxaliplatin doublet chemotherapy and 2 cycles of irinotecan doublet chemotherapy, i.e. mFOLFOX6-FOLFIRI or CAPOX-CAPIRI In both arms, initial combination chemotherapy will be given for 4-6 months as per standard of care, followed by maintenance fluoropyrimidine chemotherapy until disease progression, unmanageable toxicity or patient or treating clinician’s request. Biologic therapy (bevacizumab or an EGFR inhibitor) will be given according to clinician’s choice; however, as per guidelines, EGFRI use will be restricted to patients with left-sided RAS wild-type tumours. 1) Intervention drug - Doublet chemotherapy (mFOLFOX6, FOLFIRI, CAPOIX or CAPIRI) mFOLFOX6 Frequency: every 2 weeks Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 50 mg IV day 1 Fluorouracil (5FU) 400 mg/m2 IV day 1 Fluorouracil (5FU) infusion 2,400 mg/m2 over 46 hours day 1-2 FOLFIRI Frequency: every 2 weeks Irinotecan 180 mg/m2 IV day 1 (150 mg/m2 if > 70 y.o.) Leucovorin 50 mg IV day 1 Fluorouracil (5FU) 400 mg/m2 IV day 1 Fluorouracil (5FU) infusion 2,400 mg/m2 over 46 hours day 1-2 CAPOX Frequency: every 3 weeks Oxaliplatin 130 mg/m2 IV day 1 Capecitabine 850-1000 mg/m2 orally BD days 1-14 CAPIRI Frequency: every 3 weeks Irinotecan 240 mg/m2 IV day 1 Capecitabine 850-1000 mg/m2 orally BD days 1-14 New drug schedules have been created for the hospital staff to keep track of the alternating cycles. Whether a participant receives mFOLFOX6-FOLFIRI or CAPOX-CAPIRI is decided by the treating practitioner, based on their usual treatment practice. When a patient is on the interventional treatment e.g. CAPOX-CAPIRI, the different treatments are staggered every 3 weeks. For FOLFOX-FOLFIRI, the the different treatments are stag Primary outcome(s): To examine the feasibility of a multi-centre prospective registry-based randomised clinical trial evaluating alternating oxaliplatin and irinotecan doublet schedules vs. continuous doublet chemotherapy during initial treatment of metastatic colorectal cancer. The primary feasibility endpoint will be evaluated by recruitment rate, defined as the proportion of eligible mCRC patients who enrol onto this study. [Eligible participants will be recruited over 1.5 years. All participants will be followed until death or study completion. ] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

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Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.

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