Spatially Fractionated Radiation Treatment for Gynaecological Cancers

Launched by TATA MEMORIAL HOSPITAL · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of radiation treatment called spatially fractionated radiation therapy (RT) for women with cervical cancer or pelvic recurrences. The goal is to see how well this treatment controls the disease, improves survival, and what side effects it may cause in patients who cannot receive traditional brachytherapy (a type of internal radiation therapy). This study is specifically for women who have complex pelvic anatomy, large tumors that make it hard to target the cancer accurately, or those who are unable to undergo surgery or regular brachytherapy due to health reasons.

To participate in this trial, women aged between 65 and 75 who have cervical cancer or endometrial cancer, or those with large pelvic tumors that haven’t responded to previous treatments, may be eligible. Participants will undergo a new radiation treatment designed to better target their cancer despite their unique medical situations. It’s important to note that this study is still in the planning stages and is not yet recruiting patients. Additionally, women with certain health issues, like existing fistulas or pelvic prostheses, will not be eligible. If you or a loved one are considering this option, please discuss it with your healthcare team for more information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
• • 1. Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two independent clinicians in up to two procedures.
• • 2. Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on pre-brachytherapy imaging or at dose planning (e.g. figure 2).
• • 3. Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
• • 2. Patients with inoperable endometrial cancer not suitable for anaesthesia or have anticipated suboptimal coverage of target volume at brachytherapy as identified on pre-brachytherapy imaging obtained after EBRT.
• • 3. Patients with large pelvic recurrences after surgery and/or (chemo) radiation, not amenable to surgical salvage or brachytherapy after salvage EBRT due to reasons specified in item 1.
• • 4. Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events.
• Exclusion Criteria:
• • 1. Any pre-existing fistula in bladder or rectum.
• • 2. Pelvic prosthesis.
• • 3. Refusal to provide consent.