MR-PET Guided Biologically Optimised Interstitial Brachytherapy (MR-PET Brachy)
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|ClinicalTrials.gov Identifier: NCT01391065|
Recruitment Status : Unknown
Verified June 2011 by Tata Memorial Hospital.
Recruitment status was: Recruiting
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).
The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.
In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Radiation: MR PET Guided Brachytherapy||Phase 1 Phase 2|
Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.
Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.
Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy.
Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2017|
- Local Response in spatial reference to High Risk GTV (as identified by functional imaging) [ Time Frame: 3 months after treatment completion ]
- Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy [ Time Frame: 2 years after treatment conclusion ]Stage II involves dose modulated brachytherapy wherein higher dose will be delivered to biologically high risk target volume. Saftey will be assessed initially by an interim analysis undertaken at 50 % accrual(median follow up 1 yr). If incidence of grade III-IV rectal and bladder toxicity >15% than the trial will be stopped else continued till target accrual. The technique will be considered to be safe if Grade III bladder and bowel toxicity remain to be under 15%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391065
|Contact: Dr Supriya Chopra, MD||91-22-27405000 ext email@example.com|
|Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre||Recruiting|
|Navi Mumbai, Maharashtra, India, 410210|
|Contact: Dr Supriya Chopra, MD 91-22-27405000 ext 5491 firstname.lastname@example.org|
|Principal Investigator: Supriya Chopra, MD|