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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00423618
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma meeting the following criteria:
* Lesion originates in extremity
* Upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
* No lesions of the chest wall arising adjacent to the scapula but not originating in the shoulder bone
* Lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
* Imaging and pathology from first surgery are required
* Has undergone surgical resection of the tumor within the past 12 weeks
* No macroscopic tumor in situ after surgery
* Microscopically irradical surgical margin allowed
* Excisional biopsy with positive margins or other inadequate surgery (macroscopically involved margins) allowed only after further definitive re-excision
* Positive margins and no further surgery possible except amputation or major functional loss allowed provided no macroscopic residual disease is present
* Local recurrence within 3 months of prior surgery (or other treatment) allowed provided patient undergoes subsequent re-excision
* No diagnosis of any of the following:
* Rhabdomyosarcoma (alveolar or embryonal)
* Primitive neuroectodermal tumor
* Soft tissue Ewing's sarcoma
* Extraskeletal osteosarcoma
* Aggressive fibromatosis (desmoid tumors)
* Dermatofibrosarcoma protuberans
* Gorlin's syndrome
* No regional nodal disease or unequivocal distant metastasis
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No other major medical illness that would preclude study treatment
* No other malignancy except adequately treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy to the local site
* No prior neoadjuvant or adjuvant chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
120 Years
Study:
NCT00423618
Study Brief:
Protocol Section:
NCT00423618