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


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Major wound complications within 120 days following surgery

Outcome Time Frame:

120 days post-op

Safety Issue:

No

Principal Investigator

Brian O'Sullivan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 03-0107-C

NCT ID:

NCT00188175

Start Date:

May 2003

Completion Date:

May 2014

Related Keywords:

  • Sarcoma
  • Sarcoma

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