Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

Uterine Cervical Neoplasms Clinical Trial

— APROVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03184350
• Other study ID #: APROVE
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: June 9, 2017
• Start date: June 2017
• Est. completion date: June 2021

Study information

• Verified date: June 2017
• Source: Heidelberg University
• Contact: Nathalie Arians, MD
• Phone: +496221568202
• Email: nathalie.arians[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2021
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrial Neoplasms Malignant
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Department of radiation oncology, University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

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