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Completed

NCT Number: NCT00188175

IMRT Lower Limb Soft Tissue Sarcoma

Intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven soft tissue sarcoma
  • Lesion lies between the iliac crest (hipbone) and the ankle
  • Lesion is newly diagnosed
  • Assessed by radiation oncologist and surgical oncologist

Exclusion criteria

  • Benign histologies
  • Histologies generally treated with chemotherapy
  • Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix

Treatment and study plan

Intensity modulated radiation therapy

Radiation

Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.

Primary outcomes

  1. Major wound complications within 120 days following surgery

    Time frame: 120 days post-op

Secondary outcomes

  1. Assess acute and late radiation toxicity including limb edema

    Time frame: up to120 days

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Ontario Cancer Research Network

Registry information

Official study title

A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2005
Registry last updated
Jun 3, 2014

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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