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NCT Number: NCT02495519

A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. These tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. Therefore, effective medical therapies for AF are needed to maintain quality of life and prolong survival.The goal of the current study was to better define the activity of imatinib in the treatment of AF and to determine the molecular basis for response/nonresponse

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Key information

Conditions

Fibromatosis Fibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written consent;
  • Age ≥ 10 years;
  • Eastern Cooperative Oncology Group Performance status ≤ 2;
  • Histologically confirmed desmoid tumor;
  • Disease progression after local treatment
  • Measurable target lesion (RECIST criteria) ;
  • Adequate hematological, renal and liver functions :

Exclusion criteria

  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
  • Pregnant or lactating female
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Treatment and study plan

Imatinib

Drug

Imatinib 400 mg/day until disease progression

Primary outcomes

  1. non-progressive rate

    Time frame: 16weeks

    non-progressive rate at 16weeks

Secondary outcomes

  1. overall survival

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2015
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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