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
2 other identifiers
interventional
4
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 13, 2007
CompletedFirst Posted
Study publicly available on registry
July 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedNovember 18, 2015
November 1, 2015
12.3 years
July 13, 2007
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Toxicity of Radiation Therapy Plus Low Dose Doxorubicin in Participants with Extremity and Trunk Sarcoma
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.
6 weeks after the start of Doxorubicin
Study Arms (1)
Doxorubicin + Radiation Therapy
EXPERIMENTALDoxorubicin 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- Patients must have a Karnofsky P.S. of \> 70 or a Zubrod P.S. of 0 or 1.
- 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%.
- EKG (within 6 weeks of the planned start of treatment).
- Echocardiogram or multiple gated acquisition scan (MUGA) (if prior doxorubicin treatment or history of either myocardial infarction or congestive heart failure).
- Patients must have no uncontrolled co-existing medical conditions.
- Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.
- All patients must sign an informed consent.
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter W. Pisters, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2007
First Posted
July 17, 2007
Study Start
January 1, 2003
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
November 18, 2015
Record last verified: 2015-11