An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial

Completed

• Conditions: Sarcoma

• Registration Number: NCT00384735
• Lead Sponsor: Terry Fox Foundation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-01-01
• Study First Submitted: 2006-10-04
• Study First Submitted QC: 2006-10-04
• Study First Posted: 2006-10-06
• Primary Completion: 2010-06-30
• Study Completion: 2015-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	Minimum 2 years

Secondary Outcome Measures

Name	Time	Method
Disease free survival	Minimum 2 years

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, Maharashtra, India