Spots Global Cancer Trial Database for Clinical Study of Concurrent Pazopanib and Radiotherapy for Non-metastatic Sarcoma Patients

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Trial Identification

Brief Title: Clinical Study of Concurrent Pazopanib and Radiotherapy for Non-metastatic Sarcoma Patients

Official Title: Phase II Clinical Study of Concurrent Pazopanib for Non-metastatic Sarcoma Patients to be Treated With Radiotherapy, Localized in the Extremities, Trunk and Chest Wall or the Head and Neck Region (PASART-2)

Study ID: NCT02575066

Conditions

Sarcoma

Soft Tissue Sarcomas

Interventions

external beam radiotherapy

pazopanib

Study Description

Brief Summary: Radiotherapy (RT) alone is able to induce a clinically significant effect with a variable pathologic response (a pathological complete remission, pCR, defined as ≥ 95%, or ≤ 5% remaining visible tumour cells) in only about 10% of cases. A prior phase I study (PASART-1; NCT01985295) suggested that 25 x 2 Gy preoperative RT in combination with once daily 800mg oral pazopanib is feasible, while inducing tissue replacing tumor that can consist of fibrosis and necrosis in 40% of thus treated patients. During this study, the interim analysis showed that the combination treatment of preoperative radiation with orally pazopanib is more effective than was anticipated. For this reason, the pazopanib dose of 800 mg once daily is maintained but the RT dose is reduced to 18x2Gy instead of 25x2Gy. Predominant aim of this RT dose reduction is lowering the wound complication risk after preoperative radiotherapy.

Detailed Description: Patients of the first part of the study received radiotherapy (25x2Gy) and pazopanib (QD 800 mg). Patients of the second part of the study received/ will receive radiotherapy (18x2Gy) and pazopanib (QD 800 mg).