NCT00384735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2010

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4.5 years

First QC Date

October 4, 2006

Last Update Submit

October 5, 2020

Conditions

Sarcoma

Keywords

bone tumorsoft tissue tumor

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Minimum 2 years

Secondary Outcomes (1)

  • Disease free survival

    Minimum 2 years

Study Arms (4)

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

Eligibility Criteria

Age1 Year - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients operated for primary or recurrent extremity bone \& soft tissue sarcomas.(both limb salvage and amputations)
  • Non Metastatic at presentation.
  • Patients reliable for follow-up.

You may not qualify if:

  • Non-extremity sarcomas.
  • Metastatic at presentation
  • Patients unreliable for follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (1)

  • 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.

    PMID: 24249538DERIVED

MeSH Terms

Conditions

SarcomaBone NeoplasmsSoft Tissue Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Officials

  • Dr. Ajay Puri

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

January 1, 2006

Primary Completion

June 30, 2010

Study Completion

December 31, 2015

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

IN(1)