Clinical trial · Interventional
Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma
A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma
NCT00502411CI-TRIAL-00019844completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxorubicin + Radiation Therapy
- description
- Doxorubicin 17.5 mg/m\^2 IV bolus infusion, followed by continuous IV infusion on days 1-4. Radiation treatments 5 days a week for 6 - 6 1/2 weeks. 60 Gy in 6 weeks (negative resection margin) to 66 Gy in 6.5 weeks (positive resection margin).
- interventionNames
- Drug: Doxorubicin
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Toxicity of Radiation Therapy Plus Low Dose Doxorubicin in Participants with Extremity and Trunk Sarcoma
- timeFrame
- 6 weeks after the start of Doxorubicin
- description
- Toxicity defined by acute local toxicity to skin and subcutaneous tissues and delayed wound healing. Toxicity defined as (1) grade 3 or 4 myelosuppression with fever or (2) grade 3 or 4 desquamation, or (3) both (1) and (2), scored within 6 weeks from the start of doxorubicin treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.