Histologically based neoadjuvant approch for adults with soft tissue sarcomas of extremities and trunk wall

Phase 1

• Conditions: OCALIZED HIGH-RISK SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND TRUNK WALL IN ADULTS; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023484-17-PL
• Lead Sponsor: Italian Sarcoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-29
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Soft tissue sarcoma of adults, primary or locally recurrent, with spindle-cell or pleomorphic histology, belonging to one of the following for the randomization (Group1):
?Myxoid-Round Cell liposarcoma (cellular component >5 %)
?Leiomyosarcoma
?Synovial sarcoma
?Malignant Peripheral Nerve Sheat Tumor
?Undifferentiated pleomorphic sarcoma (ex Malignant fibrous histiocytoma)
Or belonging to one of the following for the registration (Group 2):
?Myxofibrosarcoma
?Unclassified Spindle Cell
?Pleomorphic Liposarcoma
?Pleomorphic Rabdomiosarcoma
Or belonging to either group but not being evaluable for response (re-excision after previous inadequate resection or primary definitive surgery) (Group3).

The histological diagnosis must be made according to the WHO criteria (19) and will have to be centrally reviewed before randomization.

2)High malignancy grade: grade 3 of 3, according to Coindre (20), or grade 2 at biopsy with a radiological evidence of more than 50% of necrosis in the tumor mass.
3)Deep seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) lesion.
4)Size of primary tumor (visible or previously inadequately resected) >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size.
5)Age > 18 years.
6)ECOG performance status <1 (21).
7)Adequate bone marrow function:
WBC >3.500/mm3
neutrophil >1.500/mm3
platelets >150.000/mm3
hemoglobin >11 g%.
8) Adequate renal (creatinine <1.3 mg%), and hepatic function (bilirubin <1.5 mg% and transaminases <2 x n.v. If ALP > 2.5 x ULN, ALP LF and/or GGT = ULN).
9)Adequate cardiac function (FE >50%).
10)Signed informed consent.
11)Complete compliance of the participating center with the protocol requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1)Pregnancy or lactation.
2)Distant metastasis.
3)Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent.
4)Sarcoma histotypes other than those mentioned in the inclusion criteria.
5) Prior CT and/or RT.
6)Serious psychiatric disease that precludes informed consent or limits compliance.
7)Medical disease limiting survival to less than two years, limiting compliance or which in the physician’s opinion might interfere significantly with the toxicity of the treatments.
8)Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (22).
9) Uncontrolled bacterial, viral or fungal infection.
10)Impossibility of ensuring adequate follow-up.
11)Failure to comply with the requirements of the present protocol leading to exclusion of the participating center.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified