Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if the combination of radiation therapy plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of sarcoma. The safety of this treatment will also be studied.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. All patients with cytological or histological proof of large (> 5 cm), completely resected soft tissue sarcoma of the extremity or trunk (AJCC Stage IB, IIA, IIC, and III) will be eligible. Patients with stage IV sarcoma who are considered for primary tumor treatment with surgery and postoperative radiation are also eligible.

2. Patients who have undergone pre-referral surgical resection or excisional biopsy with no measurable residual disease on appropriate radiological imaging will be eligible. The adequacy of the surgical resection will be evaluated at MDACC and re-excision will be performed as necessary. Negative surgical resection margins are desirable; positive margins, however, are allowable if re-excision would result in functional deficit.

3. Patients may have received prior doxorubicin-based systemic chemotherapy up to a total doxorubicin dose of 450 mg/m2. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman.

4. Patients must have a Karnofsky P.S. of > 70 or a Zubrod P.S. of 0 or 1.

5. Absolute neutrophil count must be > 1,500 cells/mm; platelet count > 100,000 platelets/ml; serum creatinine < 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 3 x normal, total bilirubin < 1.5 mg/dl. For patients with cumulative doxorubicin 400 - 450 mg/m2, EF > 50%.

6. EKG (within 6 weeks of the planned start of treatment).

7. Echocardiogram or multiple gated acquisition scan (MUGA) (if prior doxorubicin treatment or history of either myocardial infarction or congestive heart failure).

8. Patients must have no uncontrolled co-existing medical conditions.

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

10. All patients must sign an informed consent.

Exclusion Criteria:

1) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.