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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tata Memorial Hospital
Information provided by (Responsible Party):
Dr. Ajay Puri, Terry Fox Foundation
ClinicalTrials.gov Identifier:
NCT00384735
First received: October 4, 2006
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Phase
Sarcoma
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Terry Fox Foundation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Minimum 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: Minimum 2 years ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: January 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1A
Intensive - 3 monthly follow up
1B
Intensive - 6 monthly follow up
IIA
Cost Effective - 3 monthly follow up
IIB
Cost Effective - 6 monthly follow up

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.

  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients operated for primary or recurrent extremity bone & soft tissue sarcomas

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384735

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Terry Fox Foundation
Tata Memorial Hospital
Investigators
Principal Investigator: Dr. Ajay Puri Tata Memorial Hospital
  More Information

No publications provided by Terry Fox Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ajay Puri, Professor, Terry Fox Foundation
ClinicalTrials.gov Identifier: NCT00384735     History of Changes
Other Study ID Numbers: TOSS
Study First Received: October 4, 2006
Last Updated: July 9, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Terry Fox Foundation:
bone tumor
soft tissue tumor

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on October 30, 2014