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A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas


Phase 1
16 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas


OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin when
combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of
the extremity or trunk. II. Assess the radiographic and pathologic response rates to this
preoperative regimen in the subset of these patients with measurable disease.

OUTLINE: This is a dose escalation study of doxorubicin. Patients receive doxorubicin
intravenous (IV) bolus followed immediately by doxorubicin IV over 4 days every week for 5
weeks in the absence of unacceptable toxicity. Patients with measurable disease receive
external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin
treatment. Patients with measurable disease undergo surgical resection of the residual mass
4-7 weeks following completion of chemoradiation. Patients who have no measurable disease
and have undergone prereferral excision undergo surgical resection of the prior surgical
scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks. Cohorts
of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD)
is determined. Patients are followed every 3 months for 3 years, every 4 months for 2 years,
and then annually for 5 years.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study at a rate of 5-6
patients per month.


Inclusion Criteria:



1. Patients must have cytologic or histologic proof of large (>5 mc), Grade III,
resectable soft tissue sarcoma of the extremity or trunk (AJCC Stage IIIB). Patients
with The American Joint Committee on Cancer (AJCC) Stage IIB tumors (Grade II)
greater than 8 cms will also be eligible.

2. Patients may have measurable or non-measurable disease (C/P pre-referral excision).

3. Patients may have had prior doxorubicin (up to a total doxorubicin dose of 450
mg/m2).

4. Patients may have a prior history of malignancy (at the discretion of the Principal
Investigator).

5. Patients must have Karnofsky Point Scale (P.S.)> of >70 or Xubrod P.S. of 0 or 1.

6. Patients must have: Absolute neutrophil count (ANC) > 1,500 cells/mm; platelet count
> 100,000 platelets/ml; serum creatinine <1.8 mg/dl, aspartate aminotransferase (AST
or SGOT) and alanine aminotransferase (ALT or SGPT) < 3 times normal, total bilirubin
< 1.5mg/dl; for patients with cumulative Adriamycin 450 mg/M2, EF >50%.

7. Women of childbearing potential must not be pregnant or breast feeding and must
practice adequate contraception.

Exclusion Criteria:

1. Patients must not have had prior radiation therapy (XRT) in the area of the primary
tumor, and the anticipated XRT field must not include the perineum, scrotum, or
vaginal introitus.

2. Patients with uncontrolled coexisting medical conditions are excluded.

3. Patient must not be pregnant or brest feeding.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity

Outcome Time Frame:

Continousouly during 5 weeks treatment

Safety Issue:

Yes

Principal Investigator

Peter W. Pisters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

ID97-335

NCT ID:

NCT00004109

Start Date:

March 1998

Completion Date:

April 2011

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • Doxorubicin
  • External-Beam RT
  • XRT
  • cancer
  • PREOPERATIVE CONCURRENT CHEMORADIATION
  • EXTREMITY SOFT TISSUE SARCOMAS
  • TRUNK SOFT TISSUE SARCOMAS
  • Concurrent Chemoradiation
  • Surgical Resection
  • Localized Extremity Soft Tissue Sarcomas
  • Body Wall Soft Tissue Sarcomas
  • Sarcoma

Name

Location

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