Clinical trial NCT00004109: Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
Official title: A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma
Keywords: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Continousouly during 5 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Peter W. Pisters, MD
role: STUDY_CHAIR
References: