Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004109
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : August 2, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: Doxorubicin Hydrochloride Radiation: Radiation Therapy (RT) Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas
Study Start Date : March 1998
Actual Primary Completion Date : September 2001
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Doxorubicin + External-Beam RT Drug: Doxorubicin Hydrochloride
Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
Other Name: doxorubicin
Radiation: Radiation Therapy (RT)
External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
Other Names:
  • RT
  • Radialtherapy

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Continousouly during 5 weeks treatment ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004109

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Peter W. Pisters, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00004109     History of Changes
Other Study ID Numbers: ID97-335
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-97335 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000067332 ( Registry Identifier: NCI PDQ )
First Posted: March 15, 2004    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
External-Beam RT
Concurrent Chemoradiation
Surgical Resection
Localized Extremity Soft Tissue Sarcomas
Body Wall Soft Tissue Sarcomas

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action