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Clinical Trials in India / NCT06644846
Recruiting Not applicable

Spatially Fractionated Radiation Treatment for Gynaecological Cancers

NCT06644846 · tracked via the Priya Life Science India tracker
Sponsor
Tata Memorial Hospital
Phase
Not applicable
Started
2024-10-04
Last updated
2026-02-20

Condition(s) studied

Cervical CancerGynecologic CancerRecurrent Cancer

Investigational drug(s) / intervention(s)

Spatially fractionated radiation therapy

Spatially fractionated radiation therapy: Spatially fractionated" radiation therapy (SFRT) enables delivery of high-dose radiation to discrete sub-volumes inside a tumour target while restricting the remainder of the target to a safer lower dose. This technique results in generation of intentionally heterogeneous dose distribution with spatial areas of "hot" and "cold" spots within the tumour, thereby sparing nearby organs at risk.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • In-field control — 1-year
    To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT

Trial sites (1)

FacilityCityRegionStatus
ACTREC Tata Memorial Centre Navi Mumbai Maharashtra Recruiting

More Tata Memorial Hospital trials in India

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Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers Active, not recruiting
Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study. Recruiting

Other trials for the same condition

Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr Recruiting
Induction Chemotherapy Plus Chemoradiation as First Line Treatment for Locally Advanced Cervical Cancer Active, not recruiting
Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India Recruiting
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study Recruiting
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06644846 on ClinicalTrials.gov ↗ ← All trials in India