Spatially Fractionated Radiation Treatment for Gynaecological Cancers

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer; Gynecologic Cancer; Recurrent Cancer

• Registration Number: NCT06644846
• Lead Sponsor: Tata Memorial Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-12
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Start: 2024-10-20
• Primary Completion: 2027-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression-free and overall survival	2-years	To evaluate progression free and overall survival from the date of end of treatment upto 2 years
Late grade 2 or higher genitourinary and gastrointestinal toxicities.	> 90 days	To evaluate grade 2 or higher genitourinary and gastrointestinal toxicities from the date of end of treatment upto 90 days
To compare SFRT in-silico dose volume parameters with proton beam plans	1-year	To compare dose volume parameters of SFRT plans with proton beam plans, created on the same datasets.
To obtain biopsy tissue for translational research before and after SFRT	1-year	Programmed cell death ligand 1 (PD-L-1) expression will be studied
To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT	1-year	To evaluate overall response based on PET-FDG and hypoxia markers at baseline and before SFRT