NCT01391065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

7.9 years

First QC Date

July 1, 2011

Last Update Submit

April 3, 2020

Conditions

Cervical Cancer

Keywords

Diffusion Weighted MRIFLT PETF-Miso PETImage Guided BrachytherapyCervixPostoperative Residual Disease/Postoperative recurrences

Outcome Measures

Primary Outcomes (1)

  • Local Response in spatial reference to High Risk GTV (as identified by functional imaging)

    3 months after treatment completion

Secondary Outcomes (1)

  • Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy

    2 years after treatment conclusion

Study Arms (1)

1

OTHER

The study arm will undergo baseline multifunctional PET and MRI scans, before brachytherapy and at follow up

Radiation: MR PET Guided Brachytherapy

Interventions

MR PET Guided BrachytherapyRADIATION
1

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

Location

Related Publications (1)

  • Chopra S, Engineer R, Shah S, Shukla R, Dora T, Gupta P, Paul SN, Popat P, Swamidas J, Mahantshetty U, Varghese L, Gupta S, Rangrajan V, Shrivastava S. MRI- and PET-Guided Interstitial Brachytherapy for Postsurgical Vaginal Recurrences of Cervical Cancer: Results of Phase II Study. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):310-319. doi: 10.1016/j.ijrobp.2019.10.037. Epub 2019 Nov 1.

    PMID: 31682968DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 11, 2011

Study Start

February 23, 2011

Primary Completion

February 1, 2019

Study Completion

October 4, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

IN(1)