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

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Deep Regional Hyperthermia; Locally Advanced Rectal Cancer; Hyperthermic Chemoradiotherapy; Hyperthermia; Hyperthermic Radiochemotherapy; Rectal Cancer

Treatments: Drug: Chemotherapy (5-Fluorouracil); Radiation: Radiotherapy; Other: Deep regional hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT02353858

HT01

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

RtChx + Hyperthermia

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: Chemotherapy (5-Fluorouracil)

Other: Deep regional hyperthermia