Adjuvant Protontherapy of Cervical and Endometrial Carcinomas (APROVE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Cervical Neoplasms; Endometrial Neoplasms Malignant
• Intervention / Treatment: Radiation: Adjuvant pelvic proton radiation

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Department of radiation oncology, University Hospital Heidelberg
    • Contact: Nathalie Arians, MD; Phone Number: +496221568202; Email: nathalie.arians@med.uni-heidelberg.de
    • Contact: Karen Lossner; Phone Number: +4962215637748; Email: karen.lossner@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Juergen Debus, Prof.Dr.Dr., University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: endometrial cancer; cervical cancer; proton therapy
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: APROVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No