NCT05827458

Brief Summary

Bone and soft tissue sarcomas are rare tumors, accounting for approximately 1% of all adult malignancies. The majority of bone and soft tissue sarcomas occur in the extremities. After treatment of the primary tumor, 40 % to 60% of the patients will develop local or distant recurrent disease. The ultimate determinant of survival in patients with bone and soft tissue sarcomas is the development of distant metastasis. Modern multimodality therapy has improved patient survival; hence follow-up surveillance strategies are becoming increasingly important with significant clinical and fiscal implications. However, the ideal postoperative protocol vis a vis frequency and appropriate screening modalities for these uncommon neoplasms remains ill-defined. Although guidelines have been proposed for follow-up of patients , there is a paucity of data in medical literature on the effectiveness of these recommendations. A prospective randomized controlled trial to evaluate the effectiveness of follow up strategies in picking up disease recurrence and their role in influencing overall survival would go a long way in answering some of these questions.

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
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7.3 years until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

4.4 years

First QC Date

February 12, 2013

Last Update Submit

April 11, 2023

Conditions

Sarcomas

Keywords

bone tumorsoft tissue tumorcancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Patient survival

    10 years

Secondary Outcomes (1)

  • Disease free survival

    10 years

Study Arms (4)

I A

INTENSIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up A CT scan of the chest was done on a six-monthly basis. CXR at the intervening three-month follow-up.

I B

INTENSIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up A CT scan of the chest was done on a six-monthly basis

II A

COST EFFECTIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up with CXR

II B

COST EFFECTIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up with CXR

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

500 PATIENTS OVERALL. 250 PATIENTS ON INTENSIVE GROUP 250 PATIENTS ON COST EFFECTIVE GROUP

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 (3)

  • Cipriano CA, Jang E, Tyler W. Sarcoma Surveillance: A Review of Current Evidence and Guidelines. J Am Acad Orthop Surg. 2020 Feb 15;28(4):145-156. doi: 10.5435/JAAOS-D-19-00002.

    PMID: 31651565BACKGROUND

  • Chiesa AM, Spinnato P, Miceli M, Facchini G. Radiologic Assessment of Osteosarcoma Lung Metastases: State of the Art and Recent Advances. Cells. 2021 Mar 4;10(3):553. doi: 10.3390/cells10030553.

    PMID: 33806513BACKGROUND

  • Heinemann M, Ranft A, Langer T, Jurgens H, Kreyer J, Vieth V, Schafers M, Weckesser M, Simon T, Hassenpflug W, Corbacioglu S, Bielack S, Mayer-Steinacker R, Kuhne T, van den Berg H, Gelderblom H, Bauer S, Stegger L, Dirksen U. Recurrence of Ewing sarcoma: Is detection by imaging follow-up protocol associated with survival advantage? Pediatr Blood Cancer. 2018 Jul;65(7):e27011. doi: 10.1002/pbc.27011. Epub 2018 Feb 26.

    PMID: 29480574BACKGROUND

MeSH Terms

Conditions

SarcomaBone NeoplasmsSoft Tissue NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dr AJAY PURI, ORTHOPAEDIC ONCOLOGIST

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 12, 2013

First Posted

April 25, 2023

Study Start

January 1, 2006

Primary Completion

June 1, 2010

Study Completion

January 1, 2016

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

IN(1)