Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT01719302
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
* tumor greater than 5 cm in longest dimension
* life expectancy of at least 6 months
* Zubrod performance status of 0-2
* signed informed consent
* adequate bone marrow function defined by:
1. absolute peripheral granulocyte count of \>1500 cells/mm\^3
2. hemoglobin \>8.0 g/dl
3. platelet count \>100,000/mm\^3
4. absence of a regular red blood cell transfusion requirement
* adequate hepatic function defined by:
1. total bilirubin \<1.5 x upper limit of normal (ULN)
2. AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
* adequate renal function defined by:
1\. serum creatinine \<1.5 x ULN
* negative pregnancy test for women of child bearing potential
* willingness to use effective contraception while on treatment and for 3 months thereafter
Exclusion Criteria:
* Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
* Pregnant women or nursing mothers
* concurrent chemotherapy or radiation therapy
* severe medical problems (at the discretion of the investigator)
* history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* symptomatic brain metastases
* cirrhosis
* dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft part sarcoma (ASPS)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01719302
Study Brief:
Protocol Section:
NCT01719302