Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Phase 2

Completed

• Conditions: Rectal Cancer; Locally Advanced Rectal Cancer; Hyperthermia; Hyperthermic Radiochemotherapy; Hyperthermic Chemoradiotherapy; Deep Regional Hyperthermia
• Interventions: Other: Deep regional hyperthermia; Radiation: Radiotherapy; Drug: Chemotherapy (5-Fluorouracil)

• Registration Number: NCT02353858
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RtChx + Hyperthermia	Deep regional 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
RtChx + Hyperthermia	Radiotherapy	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
RtChx + Hyperthermia	Chemotherapy (5-Fluorouracil)	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

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate	After surgical resection (4-6 weeks after last radiotherapy fraction)

Secondary Outcome Measures

Name	Time	Method
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
Locoregional progression free survival	3 years

Trial Locations

Locations (1)

University Hospital Tübingen, Department of Radiation Oncology; 🇩🇪 Tübingen, Baden-Württemberg, Germany