Spatially Fractionated Radiation Treatment for Gynaecological Cancers

Sponsor
Tata Memorial Hospital
Study ID
NCT06644846
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Oct 16, 2024
Start date
Oct 4, 2024
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SFRT arm
    This is a single arm phase II study. All patients will receive the planned intervention ie. spatially fractionated radiation therapy using rapid rod technique.

Primary Outcome Measure

In-field control [ Time Frame: 1-year ]

Central Contacts

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