Spatially fractionated radiation for gynecologic cancers

A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers

This will try spatially fractionated radiation after external beam therapy to control cervical cancer or pelvic recurrences in people who can't have standard brachytherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Tata Memorial Hospital (other gov)
• Drugs / interventions: radiation
• Locations: 1 site (Navi Mumbai, Maharashtra)
• Trial ID: NCT06644846 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with cervical cancer or pelvic gynecologic recurrences who have completed EBRT but are not suitable for brachytherapy due to aberrant uterine/pelvic anatomy, large residual disease, very narrow vaginal canal, or inoperable endometrial cancer.

Not a fit: Patients who can undergo standard brachytherapy, have widespread metastatic disease, or have poor performance status are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control and provide a safer alternative to brachytherapy for patients with challenging anatomy or large residual pelvic disease.

How similar studies have performed: SFRT is an emerging experimental technique with limited early-phase and case-series reports suggesting potential for tumor control and manageable toxicity, but robust evidence in gynecologic cancers is currently lacking.

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.

Where this trial is running

Navi Mumbai, Maharashtra

• ACTREC Tata Memorial Centre — Navi Mumbai, Maharashtra, India (RECRUITING)

Study contacts

• Study coordinator: Supriya Chopra, MD

Conditions: Cervical Cancer, Gynecologic Cancer, Recurrent Cancer, Cervical cancer, Cancer, Recurrence, Spatially fractionated radiotherapy, Rapid rod