Cervical Cancer, Gynecologic Cancer, Recurrent Cancer
Conditions
Keywords
Cervical cancer, Cancer, Recurrence, Spatially fractionated radiotherapy, Rapid rod
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.
Interventions
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.
Sponsors
Tata Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention type: Spatially Fractionated Radiation Therapy (SFRT)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-field control | 1-year | To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Contacts
CONTACTSupriya Chopra, MD
CONTACTAnkita Gupta, MD
Outcome results
None listed