The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
Collecte de données
Néoplasmes par type histologique+1
+ Néoplasmes
+ Sarcome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1983
Date à laquelle le premier participant a commencé l'étude.Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.100 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses: Liposarcoma (round cell or pleomorphic). Fibrosarcoma. Malignant fibrous histiocytoma. Inflammatory malignant fibrous histiocytoma. Myxoid malignant fibrous histiocytoma. Malignant giant cell tumor. Angiomatoid malignant fibrous histiocytoma. Leiomyosarcoma. Malignant hemangiopericytoma. Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined). Soft tissue sarcoma resembling Ewing's sarcoma. Synovial cell sarcoma. Epithelioid sarcoma. Clear cell sarcoma. Neurofibrosarcoma. Epithelioid schwannoma. Malignant triton tumor. Angiosarcoma. Mixed malignant mesenchymoma. Alvelar soft part sarcoma. Malignant granular cell tumor. All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable. Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed. Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites. The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint. The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization. Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma. Patients without a history of any other malignant disease except basal cell carcinoma. Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function. Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Cancer Institute (NCI)
Bethesda, United StatesOuvrir National Cancer Institute (NCI) dans Google Maps