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


Phase 3
1 Year
65 Years
Open (Enrolling)
Both
Sarcoma

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Overall Survival

Outcome Time Frame:

Minimum 2 years

Safety Issue:

No

Principal Investigator

Dr. Ajay Puri

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital

Authority:

India: Institutional Review Board

Study ID:

TOSS

NCT ID:

NCT00384735

Start Date:

January 2006

Completion Date:

December 2014

Related Keywords:

  • Sarcoma
  • bone tumor
  • soft tissue tumor
  • Sarcoma

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