Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Radiotherapy
- Conditions
- Rectal Cancer
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Pathological complete response rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Radiotherapy
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
Intervention: Deep regional hyperthermia
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
Intervention: Chemotherapy (5-Fluorouracil)
Outcomes
Primary Outcomes
Pathological complete response rate
Time Frame: After surgical resection (4-6 weeks after last radiotherapy fraction)
Secondary Outcomes
- post operative morbidity(3 years)
- Number of hyperthermia treatments(At completion of hyperthermic radiochemotherapy)
- Locoregional progression free survival(3 years)
- Disease free survival(3 years)
- Distant metastases free survival(3 years)
- Overall survival(3 years)
- Acute and chronic treatment related toxicity, according to CTC criteria(3 years)