The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer

Phase 3

• Conditions: Rectal Cancer
• Interventions: Radiation: Short course of radiotherapy; Radiation: Radiochemotherapy

• Registration Number: NCT00833131
• Lead Sponsor: Polish Colorectal Cancer Study Group

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-14
• Last Update Posted: 2010-04-15
• Primary Completion: 2012-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.
• WHO performance status ≤ 2.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Short course of radiotherapy	25 Gy in 5 fractions of 5 Gy over 5 days. One week interval. Consolidating chemotherapy of 3 courses of FOLFOX4. Surgery 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil.
2	Radiochemotherapy	Conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks. Surgery 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of radiation.

Primary Outcome Measures

Name	Time	Method
The rate of patients with R0 resection	Surrogate endpoint available immediatly after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M. Sklodowska-Curie Memorial Cancer Centre; 🇵🇱 Warsaw, Poland