A trial looking at the treatment of children and young people with non-rhabdomyosarcoma soft tissue sarcomas

Phase 3

Completed

• Conditions: Cancer; Soft tissue sarcoma; Topic: National Cancer Research Network; Subtopic: Sarcoma, Paediatric Oncology; Disease: Soft Tissue

• Registration Number: ISRCTN55318937
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-19
• Study Completion: 2011-03-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Eligibility criteria for the prospective non-randomised historically-controlled trial are the following:
1. A pathologically proven diagnosis of synovial sarcoma and adult-type soft tissue sarcomas
2. No evidence of metastatic lesions
3. Age less than 21 years (20 years and 364 days) of age
4. No previous treatment except for primary surgery
5. For patients who require adjuvant chemotherapy according to protocol guidelines, no more than a 8 week-interval between the diagnostic surgical approach and the start of chemotherapy
6. For patients who require adjuvant chemotherapy according to protocol guidelines, no pre-existing illness preventing treatment (in particular renal function must be equivalent to grade 0 - 1 nephrotoxicity, no prior history of cardiac disease and normal shortening fraction [greater than 28%] and ejection fraction [greater than 47%])
7. No previous malignancy. Patients with post-irradiation soft part sarcomas could be registered and treated according to the protocol guidelines, but they will be analysed separately.
8. Diagnostic material available for pathology review
9. Available for long term follow up through the treatment centre
10. Written informed consent for treatment available

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the survival rates and the pattern of treatment failure, measured after 3 years follow up

Secondary Outcome Measures

Name	Time	Method
<br> Measured after 3 years follow up:<br> 1. Verify the impact of omission of adjuvant chemotherapy in patients with low-risk synovial sarcoma<br> 2. Investigate the role of adjuvant chemotherapy in IRS group I-II, G3, size greater than 5 cm adult type sarcoma<br> 3. Prospective evaluation of clinical/pathological prognostic factors<br> 4. Investigate the role of ifosfomide-doxorubicin regimen in improving the response rate<br> 5. Unify the treatment of NRSTS patients in Europe<br>