Spatially Fractionated Radiation Treatment for Gynaecological Cancers
Recruiting now · Not applicable
Conditions studied: Cervical Cancer, Gynecologic Cancer, Recurrent Cancer
In brief
This is a prospective study to evaluate in-field disease control, survival and late toxicity in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT. The study will include patients with primary cervical cancer or pelvic recurrence not suitable for brachytherapy in view of anticipated or actual suboptimal target coverage due to aberrant anatomy or large residual disease at the time of brachytherapy.
Key facts
- Study ID
- NCT06644846
- Run by
- Tata Memorial Hospital
- People needed
- 20
- Starts
- 2024-10-04
- Expected to finish
- 2029-02-28
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
- 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.
- 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).
- Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
- 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.
- 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.
- Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events.
You may not qualify if…
- Any pre-existing fistula in bladder or rectum.
- Pelvic prosthesis.
- Refusal to provide consent.
Where it is running
- ACTREC Tata Memorial Centre — Navi Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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