Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: Deep regional hyperthermia
* Radiation: Radiotherapy
* Drug: Chemotherapy (5-Fluorouracil)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RtChx + Hyperthermia<br>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<br>* Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.<br>Radiation: Radiotherapy<br>* Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.<br>Drug: Chemotherapy (5-Fluorouracil)<br>* 5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Hyperthermia, Radiochemotherapy, Chemoradiotherapy, Deep regional hyperthermia, pathologic complete response, Regression Grade, Locally advanced rectal cancer, complete response