ACTREC Tata Memorial Centre
Navi Mumbai, Maharashtra, 410210, India
Location status: Recruiting
NCT Number: NCT06644846
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.
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Not applicable
Navi Mumbai, Maharashtra, 410210, India
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1-year
To evaluate in-field local control patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT
Time frame: 2-years
To evaluate progression free and overall survival from the date of end of treatment upto 2 years
Time frame: > 90 days
To evaluate grade 2 or higher genitourinary and gastrointestinal toxicities from the date of end of treatment upto 90 days
Time frame: 1-year
To compare dose volume parameters of SFRT plans with proton beam plans, created on the same datasets.
Time frame: 1-year
Programmed cell death ligand 1 (PD-L-1) expression will be studied
Time frame: 1-year
To evaluate overall response based on PET-FDG and hypoxia markers at baseline and before SFRT
Contact information is provided by the study sponsor or research team.
Tata Memorial Hospital
Other Gov
A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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