Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: Rapid Rod SFRT technique as a boost alternative to brachytherapy.: The dose prescription will follow the clinical dose prescription or equivalent doses for targets and organs at risk at
Sponsors
Varian Medical Systems
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Any pre-existing fistula in bladder or rectum. 2. Pelvic prosthesis. 3. Refusal to provide consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate one-year in-field control in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RTTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. To obtain biopsy tissue for translational research before & after SFRT [programmed cell death ligand 1 (PD-L-1) expression will be studied]Timepoint: 1. At baseline (pre SFRT) 2. 4 weeks post SFRT completion;To compare SFRT in-silico dosimetry with proton beam plansTimepoint: -;To report late ( >90 days) grade 2 or higher genitourinary and gastrointestinal toxicitiesTimepoint: 1 year;To report progression-free survival and overall survivalTimepoint: 2 years;To study overall response in reference to PET FDG & Hypoxia imaging at baseline & after SFRT.Timepoint: 1. At baseline (at diagnosis) 2. 4 weeks after SFRT completion | — |
Countries
India
Contacts
Public ContactDr Supriya Chopra
ACTREC Tata Memorial Centre
Outcome results
None listed