Clinical trial NCT02353858: Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Official title: Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Locally Advanced Rectal Cancer
Hyperthermia
Hyperthermic Radiochemotherapy
Hyperthermic Chemoradiotherapy
Deep Regional Hyperthermia
Keywords: Rectal Cancer
Hyperthermia
Radiochemotherapy
Chemoradiotherapy
Deep regional hyperthermia
pathologic complete response
Regression Grade
Locally advanced rectal cancer
complete response
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pathological complete response rate
timeFrame: After surgical resection (4-6 weeks after last radiotherapy fraction)
Secondary outcomes:
measure: Locoregional progression free survival
timeFrame: 3 years
measure: Disease free survival
timeFrame: 3 years
measure: Distant metastases free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Number of hyperthermia treatments
timeFrame: At completion of hyperthermic radiochemotherapy
measure: Acute and chronic treatment related toxicity, according to CTC criteria
timeFrame: 3 years
measure: post operative morbidity
timeFrame: 3 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Radiation Oncology
state: Baden-Württemberg
Study officials:
References:
citation: Gani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Konigsrainer A, Bitzer M, Zips D. Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial. Radiother Oncol. 2021 Jun;159:155-160. doi: 10.1016/j.radonc.2021.03.011. Epub 2021 Mar 17.