Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

NCT02353858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-02-13

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353858 on ClinicalTrials.gov