Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Deep regional hyperthermia

Intervention Type OTHER

Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.

Radiotherapy

Intervention Type RADIATION

Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.

Chemotherapy (5-Fluorouracil)

Intervention Type DRUG

5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.

Interventions

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Deep regional hyperthermia

Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.

Intervention Type OTHER

Radiotherapy

Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.

Intervention Type RADIATION

Chemotherapy (5-Fluorouracil)

5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No