NCT01716949

Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer

Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively improved tumor regression allowing less aggressive surgery in primary locally advanced rectal cancer and a higher rate of curative resections in heavily pretreated locally recurrent rectal cancers. Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates, and toxicity. It is planned to include a total number of 59 patients over a period of 2.5 years.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	45 up to 50.4 Gy; daily dose 1,8 Gy, 5 days per weeks
PROCEDURE	Hyperthermia	10 sessions, therapeutic time 60 min
DRUG	5-Fluorouracil	250 mg/m\^2/d as continuous i.v. infusion on d1-14, 22-35 (may be preplaced by Capecitabine)
DRUG	Capecitabine	1650 mg/m\^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)
DRUG	Oxaliplatin	50 mg/m\^2/d as 2-hour bolus infusion on d2, 9, 23, 30

Timeline

• Start date: 2012-09-01
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2012-10-30
• Last updated: 2017-08-11

Locations

6 sites across 1 country: Germany