Registry study for metastatic Colorectal Cancer in order to collect information on the efficacy of the different treatment choices in non operable metastatic colorectal cancer across all the treatment modalities.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/004981
• Date of registration: 05-09-2014
• Prospective Registration: Yes
• Primary sponsor: TATA MEMORIAL HOSPITAL
• Public title: Registry study for metastatic Colorectal Cancer in order to collect information on the efficacy of the different treatment choices in non operable metastatic colorectal cancer across all the treatment modalities.
• Scientific title: A prospective, open label, multicentric data collection registry in order to describe treatment choices in management of metastatic Colorectal Cancer (mCRC) patients with unresectable hepatic and/ or extra hepatic disease, across treatment lines Asian Metastatic colorectal Cancer registry
• Date of first enrolment: 02-10-2014
• Target sample size: 1000
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9863
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

China, Hong Kong, India, Malaysia, Philippines, Republic of Korea, Singapore, Taiwan, Thailand

Contacts

• Name: DR SHAILESH VINAYAK SHRIKHANDE
• Affiliation: TATA MEMORIAL HOSPITAL

• Name: DR SHAILESH VINAYAK SHRIKHANDE
• Affiliation: TATA MEMORIAL HOSPITAL

Key inclusion & exclusion criteria

Inclusion criteria: -Histological adenocarcinoma of colon &/or rectum with hepatic or extra-hepatic unresectable metastases

-Treatment decision with standard therapy with or without targeted therapy is made prior to inclusion in registry by the respective Investigator & Institute
Exclusion criteria: As per the "Summary of Product Characteristics" or product label, locally approved by the Licensing Authority, for every agent

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Colorectal Cancer

Primary Outcome(s)

TO DESCRIBE TREATMENT CHOICES IN MANAGEMENT OF MCRC PATIENTS

WITH UNRESECTABLE HEPATIC AND/ OR EXTRA HEPATIC DISEASE, ACROSS TREATMENT LINESTimepoint: 3 years

Secondary Outcome(s)

-Overall Response Rates

Resection (R0, R1) and RFA rates

Progression Free/ Disease Free Survival

-Overall Survival

-Safety parameters for mCRC patients

-Tolerability of the different treatment modalities and regimens used in management of mCRC

Timepoint: 3year

Secondary ID(s)

1120

Source(s) of Monetary Support

Merck PVT. Ltd. (External) Grant to centres for administrative support for development, maintenance and implementation of the Registry.

Ethics review

Status: Approved
Approval date: 23/09/2013
Contact:

Institutional Ethics committee