Clinical trial · Interventional
Adjuvant Protontherapy of Cervical and Endometrial Carcinomas
Adjuvant Protontherapy of Cervical and Endometrial Carcinomas - A Phase-II-study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms Malignant | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant pelvic proton radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Adjuvant pelvic proton radiation
- interventionNames
- Radiation: Adjuvant pelvic proton radiation
Primary outcomes (1)
- measure
- Incidence of acute treatment-associated adverse events ≥ grade 3 [Safety and Tolerability]
- timeFrame
- 3 months
- description
- Assessment of toxicity according to the CTC AE v4.0 (Common Toxicity Criteria for adverse events)
Secondary outcomes (5)
- measure
- clinical symptoms according to the CTC AE v4.0. criteria
- timeFrame
- 2 years
- description
- clinical symptoms of any grade will be assessed
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMeixner 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. PMID 36624483
- DERIVEDArians 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. PMID 29179751