Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

NCT ID: NCT03184350

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2021-06-30

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.

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant pelvic proton radiation

Group Type: OTHER

Adjuvant pelvic proton radiation

Intervention Type: 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

Interventions

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Nils Nicolay, PD Dr. Dr.

senior physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juergen Debus, Prof.Dr.Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

Department of radiation oncology, University Hospital Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Nathalie Arians, MD

Role: CONTACT

nathalie.arians@med.uni-heidelberg.de

+496221568202

Karen Lossner

Role: CONTACT

karen.lossner@med.uni-heidelberg.de

+4962215637748

Facility Contacts

Nathalie Arians, MD

Role: primary

nathalie.arians@med.uni-heidelberg.de

+496221568202

Karen Lossner

Role: backup

karen.lossner@med.uni-heidelberg.de

+4962215637748

References

Meixner E, Wark A, Forster T, Weykamp F, Lang K, Konig L, Lindel K, Oelmann-Avendano JT, Krisam J, Schneeweiss A, Ellerbrock M, Mielke T, Horner-Rieber J, Herfarth K, Debus J, Arians N. Health-related quality of life and patient-reported symptoms after postoperative proton beam radiotherapy of cervical and endometrial cancer: 2-year results of the prospective phase II APROVE-trial. Radiat Oncol. 2023 Jan 9;18(1):5. doi: 10.1186/s13014-023-02198-4.

Reference Type: DERIVED

PMID: 36624483 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29179751 (View on PubMed)

Other Identifiers

APROVE

Identifier Type: -

Identifier Source: org_study_id