JOURNAL ONKOLOGIE – STUDIE
APROVE
Juergen Debus, Prof.Dr.Dr.
Principal Investigator
University Hospital Heidelberg
Nathalie Arians, MD
Kontakt:
Phone: +496221568202
E-Mail: nathalie.arians@med.uni-heidelberg.de» Kontaktdaten anzeigen
Karen Lossner
Kontakt:
Phone: +4962215637748
E-Mail: karen.lossner@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations
Department of radiation oncology, University Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Nathalie Arians, MD
Phone: +496221568202
E-Mail: nathalie.arians@med.uni-heidelberg.de
Karen Lossner
Phone: +4962215637748
E-Mail: karen.lossner@med.uni-heidelberg.de» Ansprechpartner anzeigen
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.
- 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
1. 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:
1. clinical symptoms according to the CTC AE v4.0. criteria (Time Frame - 2 years):
clinical symptoms of any grade will be assessed
2. Quality of life of all patients included in the study (Time Frame - 2 years):
assessed by the EORTC questionnaires QLQ-C30
3. Quality of life of cervical cancer patients included in the study (Time Frame - 2 years):
assessed by the EORTC questionnaires QLQ-CX24
4. Quality of life of endometrial cancer patients included in the study (Time Frame - 2 years):
assessed by the EORTC questionnaires QLQ-EN24
5. Progression-free survival (Time Frame - 2 years):
regular MRI-scans
Adjuvant Protontherapy of Cervical and Endometrial Carcinomas
Rekrutierend
NCT-Nummer:
NCT03184350
Studienbeginn:
Juni 2017
Letztes Update:
12.06.2017
Wirkstoff:
-
Indikation (Clinical Trials):
Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Heidelberg University
Collaborator:
-
Studienleiter
Principal Investigator
University Hospital Heidelberg
Kontakt
Kontakt:
Phone: +496221568202
E-Mail: nathalie.arians@med.uni-heidelberg.de» Kontaktdaten anzeigen
Kontakt:
Phone: +4962215637748
E-Mail: karen.lossner@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations
(1 von 1)
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Nathalie Arians, MD
Phone: +496221568202
E-Mail: nathalie.arians@med.uni-heidelberg.de
Karen Lossner
Phone: +4962215637748
E-Mail: karen.lossner@med.uni-heidelberg.de» Ansprechpartner anzeigen
Studien-Informationen
Brief 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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome:1. 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:
1. clinical symptoms according to the CTC AE v4.0. criteria (Time Frame - 2 years):
clinical symptoms of any grade will be assessed
2. Quality of life of all patients included in the study (Time Frame - 2 years):
assessed by the EORTC questionnaires QLQ-C30
3. Quality of life of cervical cancer patients included in the study (Time Frame - 2 years):
assessed by the EORTC questionnaires QLQ-CX24
4. Quality of life of endometrial cancer patients included in the study (Time Frame - 2 years):
assessed by the EORTC questionnaires QLQ-EN24
5. Progression-free survival (Time Frame - 2 years):
regular MRI-scans
Geprüfte Regime
- 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
Quelle: ClinicalTrials.gov
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