Adjuvant Protontherapy of Cervical and Endometrial Carcinomas

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Cervical Neoplasms, Endometrial Neoplasms Malignant

Intervention / Treatment
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* Radiation: Adjuvant pelvic proton radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adjuvant pelvic proton radiation<br> | Radiation: Adjuvant pelvic proton radiation<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, endometrial cancer, proton therapy