Comparison of chemotherapy after surgery versus surgery alone in non-metastatic, High risk soft tissue sarcoma.

Phase 3

• Conditions: Health Condition 1: C499- Malignant neoplasm of connective and soft tissue, unspecified

• Registration Number: CTRI/2022/10/046672
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients must satisfy all the following criteria to be eligible for the study

1. Adult patients of either sex above or equal to 18 years of age.

2. Willing to provide written informed consent.

3. Histopathologically proven soft tissue sarcoma of extremity, limb girdle or truncal wall

location undergoing curative resection either primary or recurrent cases.

4. Patients must be chemotherapy naïve.

5. Satisfactory wound healing to give chemotherapy.

6. Absence of infection

7. ECOG performance status 0, 1, or 2 at the time of study inclusion.

8. STS belonging to one of the six specific histologic subtypes:

i) Undifferentiated pleomorphic sarcoma,

ii) Synovial sarcoma,

iii) Myxoid liposarcoma,

iv) Leiomyosarcoma, and

v) Malignant peripheral nerve sheath tumour

9. Patients with High risk of relapse with an estimated 10-year pr-OS of less than 60 %

using online Sarculator. ((http://www.sarculator.com)

10. Presence of adequate contraception in fertile patients and/or agreement on patientâ??s

part after counselling to use adequate methods of contraception.

11. Women of childbearing potential must have a negative serum or urine pregnancy test at

screening.

12. Adequate haematological function (defined as an absolute neutrophil count >=1•5 Ã? 109

cells per L, platelet count >=100 Ã? 109 platelets per L, and hemoglobin >=8 g/dL [may have

been transfused]).

13. Adequate liver function (defined as a total bilirubin concentration of 2 Ã? the upper limit

of normal [ULN] range and aspartate aminotransferase and alanine aminotransferase

concentrations of <=2•5 Ã? ULN) and

14. Adequate renal function (defined as an estimated creatinine clearance >50 ml/min

according to the Cockcroft-Gault formula) functions at the time of study inclusion.

Exclusion Criteria

Patients who meet any of below criteria will be excluded from the study:

1. Patients who have a metastatic disease

2. STS arising from locations other than extremity, limb girdle or truncal wall viz retro

peritoneum and head and neck location.

3. STS of any other histological subtype other than Undifferentiated pleomorphic sarcoma,

Synovial sarcoma, Myxoidliposarcoma, Liposarcoma, Leiomyosarcoma, or Malignant

peripheral nerve sheath tumour

4. Patients with uncontrolled coronary artery disease

5. Patients with known hypersensitivity or contraindications to any study-related

medication.

6. Patients with a previous or current diagnosis of Human Immunodeficiency Virus (HIV)

7. Pregnant or breast-feeding women.

8. Patients with progressive active infection or any other severe medical condition that

could hamper adequate treatment administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the 3 years Disease Free Survival (DFS) between the two treatment arms. <br/ ><br>DFS is defined as the time from randomization to the first evidence of recurrence or death from <br/ ><br>any cause.Timepoint: Disease free survival for 3 Years between 2 Arms.

Secondary Outcome Measures

Name	Time	Method
Dose modification and discontinuation rates of chemotherapy in the patients receiving <br/ ><br>adjuvant chemotherapy.Timepoint: Throughout the Study period.;Safety in terms of toxicities according to National Cancer Institute (NCI) Common <br/ ><br>Terminology Criteria for Adverse Events (CTCAE) v5.0.Timepoint: Throughout the Study period.;To compare the 3-year Overall Survival (OS) between the two treatment arms. <br/ ><br>OS is defined as the time from randomization to the time of occurrence of death <br/ ><br>regardless of its cause.Timepoint: Overall survival for 3 Years between 2 Arms. <br/ ><br>;To compare the quality of life scales between the two groups. Quality of life (QOL) will <br/ ><br>be measured using the EORTC-QLQ-30 questionnaires at the time points specified in the <br/ ><br>protocol.Timepoint: Till End of Study.