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

Launched by CNAO NATIONAL CENTER OF ONCOLOGICAL HADRONTHERAPY · Jul 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat women with specific types of gynecological cancers that have come back after previous radiation therapy. The focus is on patients who have experienced tumors in the pelvic area and groin. The researchers are investigating the use of high-energy carbon ion therapy, which might work better than traditional radiation (like X-rays) for these tough-to-treat tumors.

To join the study, participants need to be at least 18 years old and have had a confirmed diagnosis of pelvic or groin tumor recurrence. They should also have had prior radiation treatment on their pelvis and meet certain health criteria, such as being able to carry out daily activities. Throughout the trial, participants will receive tailored treatments and regular monitoring. It’s important for potential participants to understand what the trial involves and provide their written consent to take part. This trial is currently looking for new participants, so if you or someone you know fits the eligibility criteria and is interested, it may be worth discussing with a healthcare provider.

Gender

FEMALE

Eligibility criteria

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