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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
Sponsor:
Information provided by:
Tata Memorial Hospital

Brief Summary:

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

Detailed Description:

Aims

Stage I

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.

Stage II:

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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer




Primary Outcome Measures :
  1. Local Response in spatial reference to High Risk GTV (as identified by functional imaging) [ Time Frame: 3 months after treatment completion ]

Secondary Outcome Measures :
  1. 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%.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • ECOG 0 or 1.
  • Residual/ Recurrent tumor after hysterectomy of cervical cancer.
  • No visceral metastasis.
  • No known contraindication to contrast enhanced MRI/PET scan.
  • Fit for radical treatment (radiotherapy+/-chemotherapy).

Exclusion Criteria:

  • Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.
  • Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).

Information from the National Library of Medicine

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


Contacts
Contact: Dr Supriya Chopra, MD 91-22-27405000 ext 5491 schopra@actrec.gov.in

Locations
India
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    schopra@actrec.gov.in   
Principal Investigator: Supriya Chopra, MD         
Sponsors and Collaborators
Tata Memorial Hospital

Responsible Party: Dr Supriya Chopra, Advanced Centre for Treatment,Research and Education in Cancer,Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT01391065     History of Changes
Other Study ID Numbers: TMH-IRB 843
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: June 2011

Keywords provided by Tata Memorial Hospital:
Diffusion Weighted MRI
FLT PET
F-Miso PET
Image Guided Brachytherapy
Cervix
Postoperative Residual Disease/Postoperative recurrences

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female