MedPath

Spatially Fractionated Radiation Treatment for Gynecological Cancers

Phase 2
Conditions
Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Registration Number
CTRI/2024/05/067972
Lead Sponsor
Varian Medical Systems
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-

a.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.

b.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 3).

c.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
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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