Clinical trial · Observational
An Adequate Cost Effective Follow Up Protocol For Bone and Soft Tissue Sarcomas
An Adequate Cost Effective Follow Up Protocol For Bone and Soft Tissue Sarcomas: - A Prospective Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcomas | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- I A
- description
- 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.
- label
- I B
- description
- 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
- label
- II A
- description
- COST EFFECTIVE 3 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at three-month follow-up with CXR
- label
- II B
- description
- COST EFFECTIVE 6 MONTHS Appropriate local imaging including ultrasound for soft-tissue sarcomas at six month follow-up with CXR
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDCipriano 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 31651565
- BACKGROUNDChiesa 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 33806513
- BACKGROUNDHeinemann 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 29480574