NCT02353858

Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.

Conditions

• Rectal Cancer
• Locally Advanced Rectal Cancer
• Hyperthermia
• Hyperthermic Radiochemotherapy
• Hyperthermic Chemoradiotherapy
• Deep Regional Hyperthermia

Interventions

Type	Name	Description
OTHER	Deep regional hyperthermia	Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
RADIATION	Radiotherapy	Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
DRUG	Chemotherapy (5-Fluorouracil)	5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-02-03
• Last updated: 2018-02-13

Locations

1 site across 1 country: Germany