Overview

This trial is active, not recruiting.

Condition sarcoma
Phase phase 3
Sponsor Terry Fox Foundation
Collaborator Tata Memorial Hospital
Start date January 2006
End date June 2010
Trial size 500 participants
Trial identifier NCT00384735, TOSS

Summary

The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Intensive - 3 monthly follow up
Intensive - 6 monthly follow up
Cost Effective - 3 monthly follow up
Cost Effective - 6 monthly follow up

Primary Outcomes

Measure
Overall Survival
time frame: Minimum 2 years

Secondary Outcomes

Measure
Disease free survival
time frame: Minimum 2 years

Eligibility Criteria

Male or female participants from 1 year up to 65 years old.

Inclusion Criteria: 1. Patients operated for primary or recurrent extremity bone & soft tissue sarcomas.(both limb salvage and amputations) 2. Non Metastatic at presentation. 3. Patients reliable for follow-up. Exclusion Criteria: 1. Non-extremity sarcomas. 2. Metastatic at presentation 3. Patients unreliable for follow up.

Additional Information

Official title An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
Principal investigator Dr. Ajay Puri
Description Follow up studies are performed for a variety of reasons. The detection of a recurrence of the index lesion is the foundation of surveillance. Detection of other medical conditions is a secondary benefit. Psychologically, follow up testing can serve as a source of reassurance. Whether an increased frequency of follow up and the use of various expensive imaging modalities for screening and early detection of recurrence actually results in improving overall survival of patients with extremity sarcomas is a question that remains as yet unanswered. Currently followed post -operative surveillance regimes are empirical and vary widely from centre to centre. Allocation of limited health funding should be guided by evidence based recommendations rather than empirical beliefs. An ideal surveillance regime should meet the criteria of easy implementation, accuracy and cost effectiveness. In a vast country like India where patients often travel thousands of kilometers in their search for quality medical care the frequency of routine follow up visits is as important as studying the role of expensive screening modalities while drawing up guidelines for cost effective follow up strategies. This study, a prospective randomized controlled trial, attempts to outline guidelines regarding the role of follow up vis a vis frequency and the use of various imaging modalities for early detection of recurrence in improving overall survival of patients with extremity sarcomas.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Terry Fox Foundation.