Clinical Study of Concurrent Pazopanib and Radiotherapy for Non-metastatic Sarcoma Patients (NCT02575066) | Clinical Trial Compass
TerminatedPhase 2
Clinical Study of Concurrent Pazopanib and Radiotherapy for Non-metastatic Sarcoma Patients
Stopped: stopping rule
Netherlands, United Kingdom25 participantsStarted 2016-03-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, for which the standard treatment is a combination of and radiotherapy and surgery(deep seated and/or \> 5cm according to the RECIST 1.1 criteria and/or an anticipated close resection margin and/or grade II/III according to the WHO definition)
* Age ≥ 18 years
* WHO performance status of ≤ 1
* Able and willing to undergo blood sampling for PK and PD analysis
* Able to swallow and retain oral medication
* Able and willing to undergo MRI scanning
* Able and willing to undergo tumor biopsies
* Adequate organ functions as described by the laboratory findings in the table 1. For thyroid function, the T4 and TSH values must be within normal values of the range of the participating centers
* Written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
Exclusion Criteria
* Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
* Patients with recurrent sarcomas (even without prior radiotherapy)
* Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas
* Clinically significant gastrointestinal abnormalities which might interfere with oral dosing…
What they're measuring
1
pathological near complete remission of the resected specimen which has been treated with radiotherapy