Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer (HT01)

February 12, 2018 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • University Hospital Tübingen, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge)
  • International Union Against Cancer stages II or III
  • ECOG PS 0/2
  • Informed consent

Exclusion Criteria:

  • Congestive heart failure (NYHA III/IV)
  • History of myocardial infarction within the last 6 months.
  • AV Block III
  • Total hip replacement or major metal pelvic implants
  • Cardiac pacemaker
  • Contraindications for radiochemotherapy
  • Contraindications for surgical tumor resection
  • Previous pelvic radiotherapy or chemotherapy
  • Active chronic inflammatory bowel disease
  • Collagenosis
  • Congenital diseases with increased radiosensitivity
  • Pregnancy or breastfeeding
  • Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RtChx + Hyperthermia
Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete response rate
Time Frame: After surgical resection (4-6 weeks after last radiotherapy fraction)
After surgical resection (4-6 weeks after last radiotherapy fraction)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Disease free survival
Time Frame: 3 years
3 years
Locoregional progression free survival
Time Frame: 3 years
3 years
Distant metastases free survival
Time Frame: 3 years
3 years
Number of hyperthermia treatments
Time Frame: At completion of hyperthermic radiochemotherapy
At completion of hyperthermic radiochemotherapy
Acute and chronic treatment related toxicity, according to CTC criteria
Time Frame: 3 years
3 years
post operative morbidity
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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