NCT01814969

Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.

Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced rectal cancer.

Detailed description

Overview of randomized trials conducted in patients with advanced colorectal cancer with the use of preoperative radiotherapy or radiochemotherapy clearly shows the superiority of combined therapy over surgery alone. In these studies documented a significant reduction in tumor mass as a result of preoperative radiotherapy or radiochemotherapy theoretically increases the chance of performing operations with sphincters preservation, even in cases originally eligible for abdomino - perineal resection. There is the question whether the combination of preoperative hyperfractionated radiotherapy and concurrent chemotherapy may cause the further improvement of treatment outcome in patients with locally advanced rectal cancer. Published in 2012 by Gerard et al. meta-analysis of randomized trials dedicated to the treatment of patients with advanced colorectal cancer, confirms a higher percentage of sphincters preservation in patients operated after more than 5-week interval between neoadjuvant therapy and surgery. Analysis of these issues will be taken in the current study. Comparison of the two treatment regimens as preoperative phase III study with stratification for time interval between the end of radiotherapy or radiochemotherapy and surgery may show differences that have not been seen in previously published data.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Hyperfractionated Radiochemotherapy	28 x 1.5Gy 2 times a day; gap between the fractions min. 6-8h - duration of treatment 2.5 weeks + simultaneous bolus 5-Fluorouracil (the each cycle consisted of 5-fluorouracil 325 mg/m2 per day) on 1-3 and 16-18 (last 3 days of radiotherapy).
RADIATION	Hyperfractionated Radiotherapy	28 x 1.5Gy 2 times a day; gap between the factions min. 6-8h - duration of treatment 2.5 weeks

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-12-01
• Completion: 2018-12-01
• First posted: 2013-03-20
• Last updated: 2015-05-05

Locations

1 site across 1 country: Poland