Clinical trial NCT03184350: Adjuvant Protontherapy of Cervical and Endometrial Carcinomas
Official title: Adjuvant Protontherapy of Cervical and Endometrial Carcinomas - A Phase-II-study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Cervical Neoplasms
Endometrial Neoplasms Malignant
Keywords: cervical cancer
endometrial cancer
proton therapy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. For treatment planning rectum, sigma, large and small bowel, bladder and femoral heads are defined as organs at risk. The CTV is defined according to the EORTC consensus guidelines. Treatment-associated toxicity and Quality of life will be evaluated regularly.
Primary purpose: TREATMENT

Brief summary: The APROVE study is a prospective single-center single-arm phase-II study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. The primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cervical or endometrial cancer
* Indication for postoperative radiotherapy
* Karnofsky Index ≥ 70
* Age between 18 and 80 years
* Written informed consent

Exclusion Criteria:

* patient refusal or patient incapable of consent
* implanted active medical devices with no approval for ion beam radiation
* metallic implantations in the radiation field like hip prothesis
* prior pelvic irradiation
* participation in another clinical trial which might influence the results of the APROVE trial

Primary outcomes:
measure: Incidence of acute treatment-associated adverse events ≥ grade 3 [Safety and Tolerability]
timeFrame: 3 months
Secondary outcomes:
measure: clinical symptoms according to the CTC AE v4.0. criteria
timeFrame: 2 years
measure: Quality of life of all patients included in the study
timeFrame: 2 years
measure: Quality of life of cervical cancer patients included in the study
timeFrame: 2 years
measure: Quality of life of endometrial cancer patients included in the study
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of radiation oncology, University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Juergen Debus, Prof.Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arians N, Lindel K, Krisam J, Herfarth K, Krug D, Akbaba S, Oelmann-Avendano J, Debus J. Prospective phase-II-study evaluating postoperative radiotherapy of cervical and endometrial cancer patients using protons - the APROVE-trial. Radiat Oncol. 2017 Nov 28;12(1):188. doi: 10.1186/s13014-017-0926-5.