APROVE: Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

Sponsor

Heidelberg University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03184350

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasms Endometrial Neoplasms Malignant	Radiation: Adjuvant pelvic proton radiation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Adjuvant Protontherapy of Cervical and Endometrial Carcinomas - A Phase-II-study

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Adjuvant pelvic proton radiation	Radiation: Adjuvant pelvic proton radiation 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

Arm

Intervention/Treatment

Other: Adjuvant pelvic proton radiation

Radiation: Adjuvant pelvic proton radiation

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

Outcome Measures

Primary Outcome Measures

Incidence of acute treatment-associated adverse events ≥ grade 3 [Safety and Tolerability] [3 months]
Assessment of toxicity according to the CTC AE v4.0 (Common Toxicity Criteria for adverse events)

Secondary Outcome Measures

clinical symptoms according to the CTC AE v4.0. criteria [2 years]
clinical symptoms of any grade will be assessed
Quality of life of all patients included in the study [2 years]
assessed by the EORTC questionnaires QLQ-C30
Quality of life of cervical cancer patients included in the study [2 years]
assessed by the EORTC questionnaires QLQ-CX24
Quality of life of endometrial cancer patients included in the study [2 years]
assessed by the EORTC questionnaires QLQ-EN24
Progression-free survival [2 years]
regular MRI-scans

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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