Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

Not Applicable

• Conditions: Uterine Cervical Neoplasms; Endometrial Neoplasms Malignant
• Interventions: Radiation: Adjuvant pelvic proton radiation

• Registration Number: NCT03184350
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12
• Primary Completion: 2019-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvant pelvic proton radiation	Adjuvant pelvic proton radiation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of radiation oncology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany