Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Polish Colorectal Cancer Study Group
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- The rate of patients with R0 resection
- Last Updated
- 16 years ago
Overview
Brief Summary
The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection in patients with unresectable rectal cancer.
Detailed Description
Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. The preoperative treatment in the control arm is conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks simultaneously with 5-Fu, leucovorin and oxaliplatin. Experimental group receive 25 Gy in 5 fractions of 5 Gy over 5 days and after one week interval - consolidating chemotherapy of 3 courses of FOLFOX4. Surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil or radiation. The study hypothesis is that the short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10% increase of the rate of R0 resection compared to preoperative chemoradiation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.
- •WHO performance status ≤
- •Lower border of tumour ≤ 15 cm from anal verge.
Exclusion Criteria
- •cardiac coronary arterial disease,
- •arrhythmias,
- •stroke even if they have occurred in the past and are controlled with medication
Outcomes
Primary Outcomes
The rate of patients with R0 resection
Time Frame: Surrogate endpoint available immediatly after surgery
Secondary Outcomes
- The rate of local failures(5 years)
- The rate of distant metastases(5 years)
- The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 3.0)(3 months)
- The rate of postoperative complications(30 days)
- The rate of late toxicity according to the RTOG/EORTC scale(5 years)
- The rate of complete pathological response(Surrogate endpoint available immediatly after surgery)
- Overall long-term survival(5 years)
- Progression-free long-term survival(5 years)