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Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

NCT03184350 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-06-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Juergen Debus, Prof.Dr.Dr. · University Hospital Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2019-06-30
Completion
2021-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03184350 on ClinicalTrials.gov