HT01: Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT02353858

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer Locally Advanced Rectal Cancer Hyperthermia Hyperthermic Radiochemotherapy Hyperthermic Chemoradiotherapy Deep Regional Hyperthermia	Other: Deep regional hyperthermia Radiation: Radiotherapy Drug: Chemotherapy (5-Fluorouracil)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pathological complete response rate [After surgical resection (4-6 weeks after last radiotherapy fraction)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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