Adjuvant Protontherapy of Cervical and Endometrial Carcinomas (APROVE)

Heidelberg University

Status: Unknown

Conditions: Uterine Cervical Neoplasms; Endometrial Neoplasms Malignant

Treatments: Radiation: Adjuvant pelvic proton radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03184350

APROVE

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Adjuvant pelvic proton radiation

Other group

Treatment:

Radiation: Adjuvant pelvic proton radiation