Fase II onderzoek waarin de effectiviteit van 800 mg pazopanib in tabletvorm toegevoegd aan de standaard 25x bestraling wordt onderzocht, bij patiënten met weke delen tumoren in de armen of benen, de borstkas of buikwand en het hoofd/hals gebied (PASART-2)Phase II study to investigate the efficacy of adding 800 mg oral pazopanib to standard 25 x 2 Gy radiotherapy at patients with non-metastatic SArcoma patients lokalized in the extremities, trunk and chest wall or in the head and neck regio

Conditions: non-metastatic sarcoma patients localized in the extremities, trunk and chest wall or the head and neck region
MedDRA version: 18.1Level: PTClassification code 10039491Term: SarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: LLTClassification code 10039492Term: Sarcoma boneSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-004134-95-NL

Lead Sponsor: The Netherlands Cancer Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 35

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 radiotherapy and surgery (deep seated, > 5cm according to the RECIST 1.1 criteria and/or an anticipated close resection margin, 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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 diagnosed
•Poorly controlled hypertension [defined as systolic blood pressure (SBP) of = 140 mmHg or diastolic blood pressure (DBP) of = 90mmHg]
•Unstable or serious concurrent condition (e.g., active infection requiring systemic therapy)
•Prolongation of corrected QT interval (QTc) > 480 msecs on ECG
•History of any one of more cardiovascular conditions within the past 6 months
•Macroscopic hematuria
•Hemoptysis that is clinically relevant within 4 weeks of first pazopanib
•Evidence of active bleeding or bleeding diathesis
•Prior major surgery or trauma within 28 days prior to first dose of study medication
•Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth