Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT02050919|
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : June 11, 2020
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pleomorphic Rhabdomyosarcoma Stage IIB Adult Soft Tissue Sarcoma AJCC v7 Stage III Adult Soft Tissue Sarcoma AJCC v7 Stage IV Adult Soft Tissue Sarcoma AJCC v7||Drug: Epirubicin Hydrochloride Radiation: External Beam Radiation Therapy Drug: Ifosfamide Other: Laboratory Biomarker Analysis Drug: Sorafenib Tosylate Procedure: Therapeutic Conventional Surgery||Phase 2|
I. To determine the pathologic response rate (>= 95% necrosis) after preoperative treatment with sorafenib (sorafenib tosylate), epirubicin (epirubicin hydrochloride), ifosfamide, and hypofractionated radiation for high risk soft tissue sarcomas of the extremities or body wall.
I. To further characterize the safety of sorafenib plus chemoradiotherapy, including wound complication rate.
II. To estimate time-to-event rates, including overall survival, overall disease-free survival, distant disease-free survival, and local disease-free survival in patients with high risk soft tissue sarcomas of the extremities or body wall treated with preoperative sorafenib plus chemoradiotherapy and postoperative sorafenib plus chemotherapy.
Patients receive sorafenib tosylate orally (PO) once daily (QD) on days 1-71 and 85-155, epirubicin hydrochloride intravenously (IV) over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo external beam radiation therapy (EBRT) on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98.
After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sorafenib With Chemotherapy, Radiation, and Surgery for High-Risk Soft Tissue Sarcomas|
|Actual Study Start Date :||December 3, 2013|
|Actual Primary Completion Date :||May 7, 2018|
|Actual Study Completion Date :||December 31, 2020|
Experimental: Treatment (sorafenib, chemotherapy, radiation, surgery)
Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98.
Drug: Epirubicin Hydrochloride
Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Drug: Sorafenib Tosylate
Procedure: Therapeutic Conventional Surgery
Undergo surgical resection
- Pathologic Response Rate, Defined as the Percentage of Participants With Greater Than or Equal to 95% Necrosis. [ Time Frame: Up to 5 years ]Descriptive statistical analysis will be conducted. The proportion with 95% confidence interval will be summarized.
- Levels of Toxicity [ Time Frame: Up to 5 years ]Measured as the number of Grade 3-4 Adverse Events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
- Wound Complication Rate [ Time Frame: At least 120 days ]Wound complication rate, including 1) any secondary operation for wound repair, or 2) wound management without secondary operation including invasive procedures without general or regional anesthesia, readmission for wound care, or persistent deep packing for 120 days or longer.
- Overall Survival [ Time Frame: Time from registration until death from any cause, assessed up to 2 years ]Time from registration until death, Method of Kaplan-Meier used.
- Overall Disease-free Survival (Stage IIB-III Patients) [ Time Frame: Time from surgical resection to local recurrence, distant metastatic disease, or death, whichever occurs first, assessed up to 2 years ]Time from surgical resection to local recurrence, distant metastatic disease or death, subjects with stage IV disease excluded. Method of Kaplan-Meier \used.
- Distant Disease-free Survival (Stage IIB-III Patients) [ Time Frame: Time from registration until development of distant metastatic disease or death, whichever occurs first, assessed up to 2 years ]Time from registration to development of distant metastatic disease or death, subjects with stage IV disease excluded. Method of Kaplan-Meier used.
- Local Disease-free Survival [ Time Frame: Time from surgical resection of the primary tumor until local recurrence or death, whichever occurs first, assessed up to 2 years ]Time from surgical resection of the primary tumor until local recurrence. Method of Kaplan-Meier used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050919
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Christopher Ryan||OHSU Knight Cancer Institute|