Spatially Fractionated Radiation Treatment for Gynaecological Cancers

Trial Title: Spatially Fractionated Radiation Treatment for Gynaecological Cancers

NCT ID: NCT06644846

Condition: Cervical Cancer
Gynecologic Cancer
Recurrent Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Recurrence

Conditions: Keywords:
Cervical cancer
Cancer
Recurrence
Spatially fractionated radiotherapy
Rapid rod

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Intervention type: Spatially Fractionated Radiation Therapy (SFRT)

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Spatially fractionated radiation therapy
Description: 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.
Arm group label: SFRT arm

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.

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: October 20, 2024

Completion date: February 28, 2029

Lead sponsor:
Agency: Tata Memorial Hospital
Agency class: Other

Source: Tata Memorial Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06644846