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Clinical Phase I/II Trial to Investigate Preoperative Dose-Escalated Intensity-Modulated Radiation Therapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients With Retroperitoneal Soft Tissue Sarcoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Retroperitoneal Soft Tissue Sarcoma

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Trial Information

Clinical Phase I/II Trial to Investigate Preoperative Dose-Escalated Intensity-Modulated Radiation Therapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients With Retroperitoneal Soft Tissue Sarcoma


Inclusion Criteria:



- written informed consent

- histologically confirmed, primary or locally recurrent soft tissue sarcoma of the
retroperitoneal space

- judged as at least marginally resectable

- absence of distant metastases

- tumor size ≥ 5 cm

Exclusion Criteria:

- missing written informed consent

- missing histological confirmation of soft tissue sarcoma

- Desmoid tumor (syn. aggressive fibromatosis)

- judged as gross incomplete or not resectable

- incomplete staging

- presence of distant metastases

- prior radiation therapy to the abdominal region

- participation in another clinical interventional study

- inflammatory bowel disease

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local Control Rate

Outcome Time Frame:

5 year

Safety Issue:

No

Principal Investigator

Juergen Debus, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Heidelberg

Authority:

Germany: Ethics Commission

Study ID:

RETROWTS

NCT ID:

NCT01566123

Start Date:

March 2007

Completion Date:

February 2020

Related Keywords:

  • Retroperitoneal Soft Tissue Sarcoma
  • retroperitoneal soft tissue sarcoma
  • IMRT
  • IORT
  • Sarcoma

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