NCT01013805

Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	External Beam Radiotherapy	Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy. Weeks 8-10: as per Weeks 3-5
DRUG	Oxaliplatin	Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU). Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.
DRUG	Fluorouracil	Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1. Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1. Leucovorin 200 mg/m2 Day 1 concurrent with Oxaliplatin over 2 hrs, then 2nd: 5-FU 400 mg/m2 bolus Day 1, then 3rd: 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1
DRUG	Leucovorin	Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
PROCEDURE	Surgical Resection	Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-11-16
• Last updated: 2017-07-12

Locations

1 site across 1 country: Australia