Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
NCT02353858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2018-02-13
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
- 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.
Sponsors & Collaborators
-
University Hospital Tuebingen
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- Germany
Study Locations
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