Deep Regional Hyperthermia, Hyperthermia, Hyperthermic Chemoradiotherapy, Hyperthermic Radiochemotherapy, Locally Advanced Rectal Cancer, Rectal Cancer
Conditions
Keywords
Rectal Cancer, Hyperthermia, Radiochemotherapy, Chemoradiotherapy, Deep regional hyperthermia, pathologic complete response, Regression Grade, Locally advanced rectal cancer, complete response
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.
Interventions
Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
RADIATIONRadiotherapy
Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
DRUGChemotherapy (5-Fluorouracil)
5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | After surgical resection (4-6 weeks after last radiotherapy fraction) |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | 3 years |
| Distant metastases free survival | 3 years |
| Overall survival | 3 years |
| Locoregional progression free survival | 3 years |
| Acute and chronic treatment related toxicity, according to CTC criteria | 3 years |
| post operative morbidity | 3 years |
| Number of hyperthermia treatments | At completion of hyperthermic radiochemotherapy |
Countries
Germany
Outcome results
None listed