Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Ovarian Neoplasms

Recurrence

Vulvar Neoplasms

Neoplasms, Glandular and Epithelial

Disease Attributes

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Vulvar Cancer

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.

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.

carbon ion radiation therapy

Amelia Barcellini, MD

Cristina Bono, MSc

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:

1. To describe the safety profile of carbon ion therapy.
2. To estimate the effect, in terms of survival, of carbon ion treatment

Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.

The research applies to gynecological tumors.

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

absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies

Reduction of the tumor volume \> 65% of the initial volume

Volume increase \> 73% of the initial volume.

Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

Progression free survival (PFS) with qualitative evaluation as a narrative of progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies	NCT05457595	Tumor Recurrenc... Malignant Epith... Malignant Epith... Malignant Epith...	carbon ion radi...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies	NCT05457595	Tumor Recurrenc... Malignant Epith... Malignant Epith... Malignant Epith...	carbon ion radi...	18 Years -	CNAO National Center of Oncological Hadrontherapy

Spots Global Cancer Trial Database for malignant epithelial tumor of ovary