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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: November 13, 2014
Last verified: November 2014

October 4, 2006
November 13, 2014
January 2006
June 2010   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Minimum 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00384735 on ClinicalTrials.gov Archive Site
Disease free survival [ Time Frame: Minimum 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Sarcoma
Not Provided
  • 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
Puri A, Gulia A, Hawaldar R, Ranganathan P, Badwe RA. Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Clin Orthop Relat Res. 2014 May;472(5):1568-75. doi: 10.1007/s11999-013-3385-9. Epub 2013 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
June 2015
June 2010   (final data collection date for primary outcome measure)

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.
Both
1 Year to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00384735
TOSS
Yes
Dr. Ajay Puri, Terry Fox Foundation
Terry Fox Foundation
Tata Memorial Hospital
Principal Investigator: Dr. Ajay Puri Tata Memorial Hospital
Terry Fox Foundation
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP