Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Not Applicable

Recruiting

• Conditions: Tumor Recurrence; Malignant Epithelial Neoplasm of Vulva; Malignant Epithelial Tumor of Ovary; Malignant Epithelial Neoplasm

• Registration Number: NCT05457595
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-7-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients = 18 years of age<br><br> - Karnofsky Index = 70<br><br> - Histological or radiological diagnosis of pelvic and groin recurrence<br><br> - Contraindications for radical surgery<br><br> - No other distant progression or stable disease (SD) of known secondarisms (=6<br> months)<br><br> - Previous radiation therapy on pelvis<br><br> - Distance = 10mm between tumour and close intestinal tract (small intestine),<br> radiologically evaluated<br><br> - Possibility to perform a surgery to space the intestinal loops, in case of distance<br> < 10mm<br><br> - If needed, spacer in biocompatible material (silicon, goretex) or anatomical<br> material (omentum, muscle patch), non-absorbable.<br><br> - DICOM (Digital Imaging and COmmunications in Medicine) images of the previous<br> treatment plan availability<br><br> - Written informed consent<br><br> - Patient's ability to understand the characteristics and consequences of the clinical<br> trial<br><br>Exclusion Criteria:<br><br> - Hip prosthesis, metal prostheses or any other condition that prevents adequate<br> imaging to identify the target volume and calculate the dose in the treatment plan<br><br> - Intestinal infiltration<br><br> - Bladder infiltration<br><br> - Vessel infiltration<br><br> - Previous therapy with anti-angiogenesis drugs<br><br> - Psychic or other disorders that may prevent informed consent<br><br> - Previous invasive tumor, with the exception of skin cancer (excluding melanoma)<br> unless disease-free for at least 3 years<br><br> - Spacer in absorbable material (i.e. vycril)<br><br> - Distance < 10mm between tumour and close intestinal tract (small intestine),<br> radiologically evaluated<br><br> - Impossibility to assess MRI

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local control;complete response;partial response;stable disease;progression disease

Secondary Outcome Measures

Name	Time	Method
overall survival;Toxicity assessment according to CTCAE v. 5;Progression free survival