RecruitingNot Applicable

Spatially Fractionated Radiation Treatment for Gynaecological Cancers

India20 participantsStarted 2024-10-04

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Any pre-existing fistula in bladder or rectum.
✕. Pelvic prosthesis.
✕. Refusal to provide consent.

What they're measuring

In-field control

Timeframe: 1-year

Trial details

NCT IDNCT06644846

SponsorTata Memorial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-02-28

Contact for this trial

Supriya Chopra, MD

022-68735000 supriyasastri@gmail.com

View on ClinicalTrials.gov More Cervical Cancer trials