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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
ACTREC Tata Memorial Centre
Navi Mumbai, Maharashtra, India
In-field control
To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
Time frame: 1-year
Progression-free and overall survival
To evaluate progression free and overall survival from the date of end of treatment upto 2 years
Time frame: 2-years
Late grade 2 or higher genitourinary and gastrointestinal toxicities.
To evaluate grade 2 or higher genitourinary and gastrointestinal toxicities from the date of end of treatment upto 90 days
Time frame: > 90 days
To compare SFRT in-silico dose volume parameters with proton beam plans
To compare dose volume parameters of SFRT plans with proton beam plans, created on the same datasets.
Time frame: 1-year
To obtain biopsy tissue for translational research before and after SFRT
Programmed cell death ligand 1 (PD-L-1) expression will be studied
Time frame: 1-year
To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT
To evaluate overall response based on PET-FDG and hypoxia markers at baseline and before SFRT
Time frame: 1-year
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