Re-irradiation for pelvic recurrences of gynecological cancers
Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
This study is testing if a special type of radiation therapy can help people with recurring gynecological cancers in the pelvis who have already had radiation treatment before.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | CNAO National Center of Oncological Hadrontherapy Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pavia, Pv) |
| Trial ID | NCT05457595 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of carbon ion radiation therapy (CIRT) in treating patients with lateral pelvic recurrences of gynecological malignancies that have previously undergone radiation. The primary aim is to assess clinical response rates, while secondary aims include analyzing the safety profile of CIRT and its impact on patient survival. Patients eligible for this study must have specific criteria, including prior radiation therapy and the ability to undergo necessary imaging. The study is conducted at the CNAO National Center of Oncological Hadrontherapy in Pavia, Italy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of pelvic and groin recurrence of gynecological malignancies who are not suitable for radical surgery.
Not a fit: Patients with conditions that prevent adequate imaging or those with distant progression of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved local control and survival rates for patients with recurrent gynecological cancers.
How similar studies have performed: Other studies utilizing carbon ion therapy have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Pv
- Cnao — Pavia, Pv, Italy (Recruiting)
Study contacts
- Principal investigator: Amelia Barcellini, MD — CNAO National Center of Oncological Hadrontherapy
- Study coordinator: Amelia Barcellini, MD
- Email: amelia.barcellini@cnao.it
- Phone: 390382075501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.