Collection of the Data in a Standardized manner for head and neck cancer patient treated with radiation therapy (Brachytherapy)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/06/008726
• Date of registration: 01-06-2017
• Prospective Registration: Yes
• Primary sponsor: Tata Memorial Centre
• Public title: Collection of the Data in a Standardized manner for head and neck cancer patient treated with radiation therapy (Brachytherapy)
• Scientific title: ENTCOBRA: Standardized Data Collection (SDC) for head neck cancer patients treated with brachytherapy - ENT-COBRA trial
• Date of first enrolment: 10-07-2017
• Target sample size: 2000
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18325
• Study type: Observational
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Germany, Hungary, India, Italy, Spain, Sweden

Contacts

• Name: Dr Ashwini Budrukkar
• Affiliation: Tata Memorial Centre

• Name: Dr Ashwini Budrukkar
• Affiliation: Tata Memorial Centre

Key inclusion & exclusion criteria

Inclusion criteria: All patients who have undergone brachytherapy for head neck cancer at our centre.
Exclusion criteria: The patient who are not treated with the Brachytherapy.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- ENT Cancer patient treated with Brachytherapy Radiation

Primary Outcome(s)

The primary and general objective of COBRA is to facilitate the development and validation of multi-factorial prediction models for different treatment outcomes.

To develop, validate, and improve prediction models for overall survival, local control, disease-free survival, and metastasis-free survival;

To develop, validate, and improve prediction models for acute and late radiation-induced side effects relevant for cancer patients;

Timepoint: The data will be analysed retrospectively of 250 patients treated in between 2008-2016

Secondary Outcome(s)

The long term aim is to build a Decision Support System (DSS) based on validated prediction models in order to be able to personalize treatments in terms of both treatmentâ??s efficacy and treatmentâ??s toxicity control.Timepoint: We have treated 250 patients between 2008-2016 for retrospective analysis

Secondary ID(s)

1831 version 2.0 Dated 15/02/2017

Source(s) of Monetary Support

Tata Memorial Centre Dr E Borges road Parel Mumbai

Ethics review

Status: Approved
Approval date: 15/02/2017
Contact:

Institutional Ethics Committee