Overview
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Status:
Completed
Completed
Trial end date:
2017-12-01
2017-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital TuebingenTreatments:
Fluorouracil
Criteria
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