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Trial record 1 of 1 for:    NCT03184350
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Adjuvant Protontherapy of Cervical and Endometrial Carcinomas (APROVE)

This study is currently recruiting participants.
Verified June 2017 by Nils Nicolay, PD Dr. Dr., Heidelberg University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03184350
First Posted: June 12, 2017
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nils Nicolay, PD Dr. Dr., Heidelberg University
  Purpose
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.

Condition Intervention
Uterine Cervical Neoplasms Endometrial Neoplasms Malignant Radiation: Adjuvant pelvic proton radiation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
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. For treatment planning rectum, sigma, large and small bowel, bladder and femoral heads are defined as organs at risk. The CTV is defined according to the EORTC consensus guidelines. Treatment-associated toxicity and Quality of life will be evaluated regularly.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Protontherapy of Cervical and Endometrial Carcinomas - A Phase-II-study

Further study details as provided by Nils Nicolay, PD Dr. Dr., Heidelberg University:

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


Secondary Outcome Measures:
  • clinical symptoms according to the CTC AE v4.0. criteria [ Time Frame: 2 years ]
    clinical symptoms of any grade will be assessed

  • Quality of life of all patients included in the study [ Time Frame: 2 years ]
    assessed by the EORTC questionnaires QLQ-C30

  • Quality of life of cervical cancer patients included in the study [ Time Frame: 2 years ]
    assessed by the EORTC questionnaires QLQ-CX24

  • Quality of life of endometrial cancer patients included in the study [ Time Frame: 2 years ]
    assessed by the EORTC questionnaires QLQ-EN24

  • Progression-free survival [ Time Frame: 2 years ]
    regular MRI-scans


Estimated Enrollment: 25
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184350


Contacts
Contact: Nathalie Arians, MD +496221568202 nathalie.arians@med.uni-heidelberg.de
Contact: Karen Lossner +4962215637748 karen.lossner@med.uni-heidelberg.de

Locations
Germany
Department of radiation oncology, University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Nathalie Arians, MD    +496221568202    nathalie.arians@med.uni-heidelberg.de   
Contact: Karen Lossner    +4962215637748    karen.lossner@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Juergen Debus, Prof.Dr.Dr. University Hospital Heidelberg
  More Information

Responsible Party: Nils Nicolay, PD Dr. Dr., senior physician, Heidelberg University
ClinicalTrials.gov Identifier: NCT03184350     History of Changes
Other Study ID Numbers: APROVE
First Submitted: June 9, 2017
First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nils Nicolay, PD Dr. Dr., Heidelberg University:
cervical cancer
endometrial cancer
proton therapy

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases