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NCT Number: NCT06644846

Spatially Fractionated Radiation Treatment for Gynaecological Cancers

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.

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Key information

About this study

Patients will be treated with spatially fractionated radiation therapy (SFRT) after EBRT completion to a dose of 25-30 Gy in 5-6 fractions in the primary setting. For patients receiving re-irradiation, 20-25 Gy in 4-5 fractions will be delivered with SFRT, which however may be individualised to match with clinical practice in the re-RT setting. Total EQD2 Gy for organs at risk will be matched to brachytherapy.

The study will be conducted at Tata Memorial Hospital, Mumbai and Advanced Centre for Treatment, Research and Education In Cancer (ACTREC), Navi Mumbai.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spatially fractionated radiation therapy

Radiation

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.

Primary outcomes

  1. In-field control

    Time frame: 1-year

    To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT

Secondary outcomes

  1. Progression-free and overall survival

    Time frame: 2-years

    To evaluate progression free and overall survival from the date of end of treatment upto 2 years

  2. Late grade 2 or higher genitourinary and gastrointestinal toxicities.

    Time frame: > 90 days

    To evaluate grade 2 or higher genitourinary and gastrointestinal toxicities from the date of end of treatment upto 90 days

  3. To compare SFRT in-silico dose volume parameters with proton beam plans

    Time frame: 1-year

    To compare dose volume parameters of SFRT plans with proton beam plans, created on the same datasets.

  4. To obtain biopsy tissue for translational research before and after SFRT

    Time frame: 1-year

    Programmed cell death ligand 1 (PD-L-1) expression will be studied

  5. To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT

    Time frame: 1-year

    To evaluate overall response based on PET-FDG and hypoxia markers at baseline and before SFRT

Study contacts

Contact information is provided by the study sponsor or research team.

Ankita Gupta, MD

CONTACT

[email protected]

9592750011

Supriya Chopra, MD

CONTACT

[email protected]

022-68735000 ext. 5113

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 16, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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