Single Application Brachytherapy in Cervical Cancer

November 6, 2018 updated by: Dr Umesh Mahantshetty, Tata Memorial Hospital

A Feasibility and Safety Study of Single Application Multi-fractionated High Dose Rate (HDR) Brachytherapy in Locally Advanced Cervical Cancer

The purpose of the study is to evaluate safety and feasibility of single brachytherapy application with dose delivery in multiple fractions. Study will be conducted in Phase I/II clinical trial setting with strict Image guidance protocol.This study is expected reduce treatment duration and to increase ease and acceptability of brachytherapy in patients along with significant saving of resources

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Brachytherapy for cervical cancers has evolved a long way from the era of Manchester based point A prescription to volume-based prescription in the current era of 3 Dimensional (3D) imaging. Advancement in imaging technology and widespread availability of this technology has allowed most centers worldwide to incorporate Image guided brachytherapy as a routine part of their clinical practice.

The primary advantage of 3D image guided brachytherapy is that it allows the dose given by brachytherapy to conform to the anatomy of each individual patient while reducing the doses to organs at risk (OAR) (1). This technique has shown to improve local control rates and also reduce the rates of moderate to severe morbidity in multiple single institutional series (2-6). However, treatment related urinary and gastrointestinal late morbidity is still a significant problem with the 3 year actuarial incidence of intermediate to major morbidity (Grade≥2) being 30% and 29% for urinary and gastrointestinal side effects, respectively and Major morbidity (Grade≥3) is seen in 7% and 8%, respectively [An intErnational study on MRI guided BRachytherapy in locally Advanced CErvical cancers (EMBRACE) study 2014, work in progress(7)].

Most important factor determining late toxicities in radiotherapy is dose per fraction and total dose (total BEDGy3) rather than rate of dose accumulation or number of applications, which is evident from many trials of HDR brachytherapy.

The dose per fraction in the protocol of 9Gy, 7Gy and 7Gy HDR is effective in terms of local control rates and toxicities which has been published(8,9).

Our study is designed to evaluate the feasibility to deliver complete course of HDR brachytherapy in a single application while achieving dose constraints to OARs and keeping in account inter-fraction variation of doses to OAR's.

In the protocol proposed here, The Investigators intend to deliver fractionated treatments in a strict image based and quality controlled environment to minimize the doses to OAR's. Also if the constraints are not achieved, patients would be offered Standard brachytherapy regimen. This would ensure that the anticipated late toxicities would be minimized.

This study is expected to decrease overall treatment time and increase the ease and acceptability of brachytherapy in patients and with significant saving of resources while maintaining disease control rates and toxicity rates similar to standard protocols.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically diagnosed invasive cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma)
  • International Federation of Gynecology and Obstetrics (FIGO) stage 2b-4a after thorough clinical examination and work-up investigation
  • Suitable for radical radiation therapy with/without chemotherapy, and also for brachytherapy boost
  • Accepts the Informed consent process and signs the form on his/her will.

Exclusion Criteria:

  • Patients with vesico-vaginal fistula or recto-vaginal fistula at diagnosis
  • Patients at high risk of anaesthesia and patients with phobia /contra-indications to undergo MRI
  • Patients not suitable for brachytherapy
  • Metastatic disease beyond iliac on standard imaging
  • Vault cancers/recurrence
  • Previous history of pelvic radiation
  • Non-compliance to treatment
  • Medical or psychological illness precluding treatment protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single application brachytherapy
After external beam radiotherapy with or without chemotherapy as per standard, each study patient will undergo single application brachytherapy to deliver 3 High Dose Rate (HDR) fractions [1st, 2nd and 3rd fractions of doses 9 Gy, 7 Gy and 7 Gy respectively] keeping 6-12 hours of interval. All patients will undergo an inter-fraction Computed Tomography (CT) scan before delivery of second fraction. Plan will be re-optimized to reduce the dose to Organs at Risk (OAR's), only if the dose exceeds the dose constraints. Dose constraints being exceedingly hard in 1st fraction or before 2nd fraction even after re-planning will deem patient non-feasible but optimization will be done to give preference to OAR's while accepting some compromise in target doses.
Radiation: Single application multi-fraction brachytherapy
Single application brachytherapy procedure to deliver high dose rate fractions of 9Gy, 7Gy and 7Gy with 6-12 hours apart under strict image guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants achieving specified dosimetric constraints
Time Frame: 1 year
Number of participants achieving protocol specified dosimetric constraints will be measured, these dosimetric constraints are considered as a measure of safety. If not more than 20% of participants fail to achieve dosimetric constraints, trial will be considered feasible.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as assessed by CTCAE v 4.0
Time Frame: 2 years
To assess toxicity outcomes in terms of treatment related late Gastrointestinal (GI) / Genitourinary (GU) / Vaginal toxicities (grade 3 or more)
2 years
Local control rate
Time Frame: 2 years
Status of local disease at 2 years after treatment
2 years
Percentage Inter-fraction dose variation
Time Frame: 1 year
To evaluate inter fraction dose variation for organs at risk
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: Umesh Mahantshetty, MD, DNB, Professor, Department of Radiation oncology, Tata memorial Centre, Mumbai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2017

Primary Completion (Anticipated)

April 17, 2019

Study Completion (Anticipated)

April 17, 2020

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMH-1759
  • REF/2017/03/013733 (Registry Identifier: Clinical Trial Registry - India)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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