Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644846
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Spatially Fractionated Radiation Treatment for Gynaecological Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
The study will be conducted at Tata Memorial Hospital Mumbai and Advanced Centre for Treatment Research and Education In Cancer ACTREC Navi Mumbai
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None