Trials / Recruiting
RecruitingNCT05457595
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- CNAO National Center of Oncological Hadrontherapy · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).
Detailed description
Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies. Secondary aims: 1. To describe the safety profile of carbon ion therapy. 2. To estimate the effect, in terms of survival, of carbon ion treatment
Conditions
- Tumor Recurrence
- Malignant Epithelial Neoplasm of Vulva
- Malignant Epithelial Tumor of Ovary
- Malignant Epithelial Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | carbon ion radiation therapy | CIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks. Treatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted. |
Timeline
- Start date
- 2021-02-24
- Primary completion
- 2028-02-24
- Completion
- 2028-02-25
- First posted
- 2022-07-14
- Last updated
- 2025-08-06
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05457595. Inclusion in this directory is not an endorsement.