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Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, March 2008

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502411
  Purpose

Primary Objective:

1. To establish the efficacy and toxicity of post-operative continuous infusion doxorubicin with concurrent external-beam radiotherapy (EBRT) in patients with extremity and trunk sarcoma.


Condition Intervention Phase
Soft Tissue Sarcoma
Drug: Doxorubicin
Radiation: Radiation Therapy
Phase I

MedlinePlus related topics:   Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of this treatment will also be studied. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   36
Study Start Date:   January 2003
Estimated Primary Completion Date:   January 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Doxorubicin + Radiation Therapy
Drug: Doxorubicin
17.5 mg/m^2 IV bolus infusion, followed by continuous IV infusion on days 1-4.
Radiation: Radiation Therapy
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).

Detailed Description:

Doxorubicin is a drug that is commonly used to treat certain kinds of cancer.

Before the start of treatment, you will have a physical exam. You will have blood (around 2 tablespoons) and urine tests. You will have a chest x-ray and a MRI of the tumor site. If the doctor feels it is necessary, you will have a CT scan of the abdomen, an echocardiogram, and/or a MUGA scan. Women who are able to have children must have a negative blood pregnancy test.

The radiation treatment and chemotherapy will start around 4-6 weeks after surgery. During the study, you will receive radiation treatments 5 days a week for 6 - 61/2 weeks. On Day 1 of each week of radiation therapy, you will be given doxorubicin through a continuous injection into a vein for 4 days in a row. A special tube is placed into a large vein in the neck or chest region or through a large vein in the arm. This is called a central venous line. A small pump is then used to give the drug. This pump is about the size of a pack of cigarettes. You will receive appropriate instructions for the maintenance of the pump. The doxorubicin and radiotherapy will be given on an outpatient basis at M. D. Anderson.

If the disease gets worse or you experience any intolerable side effects, chemotherapy and/or radiation therapy may be stopped and you may be taken off the study. At that time, your doctor will discuss other treatment options with you.

Before the start of each week of treatment, you will have a physical exam and blood tests (around 2 tablespoons). You will also have a MRI to check on the status of the disease.

After the study, you will have follow-up visits at M. D. Anderson every 3-4 months for the first 2 years after the study then every 6 months for the next 3 years. After that you will have follow-up visits once a year for the rest of your life to check on the status of the disease. At every follow-up visit you will have ultrasound scans. You will have a MRI at the first follow-up visit then only when the doctor feels it is necessary.

This is an investigational study. Doxorubicin is FDA approved and is commercially available. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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 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.
  • 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, SGOT/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 MUGA scan (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.

Exclusion Criteria:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502411

Contacts
Contact: Peter W. Pisters, MD     713-794-1572    

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Peter W. Pisters, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Peter W. Pisters, MD     U.T.M.D. Anderson Cancer Center    
  More Information

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Peter W. Pisters, MD/Professor )
Study ID Numbers:   ID02-336
First Received:   July 13, 2007
Last Updated:   March 25, 2008
ClinicalTrials.gov Identifier:   NCT00502411
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Soft Tissue Sarcoma  
External Beam Radiotherapy  
Radiation Therapy  
Extremity and Trunk  
EBRT
Sarcoma
Doxorubicin

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Doxorubicin
Soft tissue sarcomas

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008




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