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A Phase I Study of Preoperative Chemoradiation and Intraoperative Radiation Therapy in the Treatment of Retroperitoneal Sarcoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Phase I Study of Preoperative Chemoradiation and Intraoperative Radiation Therapy in the Treatment of Retroperitoneal Sarcoma


OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of preoperative external
beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy
in patients with resectable primary or recurrent soft tissue sarcoma of the retroperitoneum.
II. Assess radiologic and pathologic response in patients treated with this preoperative
regimen.

OUTLINE: This is a dose-escalation study of external beam radiotherapy. Patients receive
doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5
weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks. Patients with
stable or responding disease undergo surgical resection of primary tumor and all adjacent
gross disease approximately 6 weeks after completion of chemoradiotherapy. Patients receive
intraoperative radiotherapy (IORT) to the tumor bed if all gross disease has been resected
and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within
a single IORT field (maximum 15 cm). Cohorts of 3-6 patients receive escalating doses of
external beam radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting
toxicity.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven resectable primary or
recurrent soft tissue sarcoma of the retroperitoneum Greatest dimension of the
3-dimensional assessment of tumor size must be 5-35 cm Grade 2 or 3, including
dedifferentiated liposarcoma and retroperitoneal recurrences of gastrointestinal
leiomyosarcoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Zubrod 0
or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than
2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Renal function
normal Creatinine less than 1.6 mg/dL Gastrointestinal: Must maintain adequate oral
nutrition (90-100% of estimated need for calories and protein) and be free of nausea and
vomiting prior to radiotherapy (feeding tube allowed) Other: Prior malignancy allowed at
the discretion of the protocol investigator No other serious uncontrolled medical
condition Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy Surgery:
See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Preoperative External Beam Radiotherapy, Doxorubicin + Intraoperative Radiotherapy

Outcome Description:

The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Peter W. Pisters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID95-225

NCT ID:

NCT00004123

Start Date:

July 1997

Completion Date:

October 2009

Related Keywords:

  • Sarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • Sarcoma

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009