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

NCT02575066 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-06-27

No results posted yet for this study

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.

Conditions

  • Sarcoma
  • Soft Tissue Sarcomas

Interventions

RADIATION

external beam radiotherapy

external beam radiotherapy 25 x 2 Gy / 18 x 2 Gy

DRUG

pazopanib

pazopanib QD 800 mg

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Rick Haas, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-17
Primary Completion
2019-03-20
Completion
2019-03-20

Countries

  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575066 on ClinicalTrials.gov