Spatially Fractionated Radiation Treatment for Gynaecological Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spatially fractionated radiation therapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Gynecologic Cancer, Recurrent Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
Overview
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.
Detailed description
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.
Interventions
- Radiation 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.
Primary outcome measures
- In-field control [Time frame: 1-year]
Secondary outcome measures (5)
- Progression-free and overall survival [Time frame: 2-years]
- Late grade 2 or higher genitourinary and gastrointestinal toxicities. [Time frame: > 90 days]
- To compare SFRT in-silico dose volume parameters with proton beam plans [Time frame: 1-year]
- To obtain biopsy tissue for translational research before and after SFRT [Time frame: 1-year]
- To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT [Time frame: 1-year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- ACTREC Tata Memorial Centre — Navi Mumbai
Identifiers
NCT: NCT06644846 · TMC IEC III 900965