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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbon ion radiotherapy | Experimental | All enrolled subjects will undergo carbon ion radiation therapy. Patients affected by pelvic recurrence of gynecological neoplasia, already undergone to radiotherapy on pelvis, will be enrolled in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon ion radiation therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| local control | absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies | 1 year after treatment |
| complete response | complete regression of the tumor lesion | 1 year after treatment |
| partial response | Reduction of the tumor volume > 65% of the initial volume | 1 year after treatment |
| stable disease | Volume between PR and PD | 1 year after treatment |
| progression disease | Volume increase > 73% of the initial volume. | 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | overall survival | 1 year after treatment |
| Toxicity assessment according to CTCAE v. 5 | Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0) |
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Inclusion Criteria:
Exclusion Criteria:
Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
The research applies to gynecological tumors.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Barcellini, MD | Contact | 390382075501 | amelia.barcellini@cnao.it | |
| Cristina Bono, MSc | Contact | 390382075613 | cristina.bono@cnao.it |
| Name | Affiliation | Role |
|---|---|---|
| Amelia Barcellini, MD | CNAO National Center of Oncological Hadrontherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNAO | Recruiting | Pavia | Pv | 27100 | Italy |
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Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.
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|
| 1 year after treatment |
| Progression free survival | Progression free survival (PFS) with qualitative evaluation as a narrative of progression | 1 year after treatment |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D014846 | Vulvar Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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