Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

— HT01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353858
• Other study ID #: HT01
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2014
• Last updated: February 12, 2018
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Regional Hyperthermia
• Fever
• Hyperthermia
• Hyperthermic Chemoradiotherapy
• Hyperthermic Radiochemotherapy
• Locally Advanced Rectal Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Tübingen, Department of Radiation Oncology	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate		After surgical resection (4-6 weeks after last radiotherapy fraction)
Secondary	Locoregional progression free survival		3 years
Secondary	Disease free survival		3 years
Secondary	Distant metastases free survival		3 years
Secondary	Overall survival		3 years
Secondary	Number of hyperthermia treatments		At completion of hyperthermic radiochemotherapy
Secondary	Acute and chronic treatment related toxicity, according to CTC criteria		3 years
Secondary	post operative morbidity		3 years