Spatially fractionated radiation for gynecologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with primary cervical cancer or pelvic recurrence who are unsuitable for brachytherapy because of aberrant anatomy, large residual disease, or a very narrow vaginal canal will receive spatially fractionated radiation after completing external beam radiotherapy. In the primary setting SFRT is given as 25–30 Gy in 5–6 fractions, while re-irradiation patients receive 20–25 Gy in 4–5 fractions with allowance for individualization. Total organ-at-risk dose (EQD2) will be matched to brachytherapy constraints to limit late toxicity. The trial at Tata Memorial Hospital and ACTREC will collect data on in-field disease control, survival, and late toxicity.

Why it matters

Who can join: the full rules

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.

Where it's running

• ACTREC Tata Memorial Centre
  Navi Mumbai, Maharashtra, India Recruiting

Study contacts

• Study coordinator: Supriya Chopra, MD
• Email: supriyasastri@gmail.com
• Phone: 022-68735000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.