Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502411
First received: July 13, 2007
Last updated: March 4, 2014
Last verified: March 2014

July 13, 2007
March 4, 2014
January 2003
January 2016   (final data collection date for primary outcome measure)
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: 7 Years ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00502411 on ClinicalTrials.gov Archive Site
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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

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.

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Soft Tissue Sarcoma
  • Drug: Doxorubicin
    17.5 mg/m^2 IV bolus infusion, followed by continuous IV infusion on days 1-4.
    Other Names:
    • AD
    • Hydroxydaunomycin hydrochloride
  • 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).
    Other Names:
    • XRT
    • RT
    • Radiotherapy
Experimental: Doxorubicin + Radiation Therapy
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).
Interventions:
  • Drug: Doxorubicin
  • Radiation: Radiation Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
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January 2016   (final data collection date for primary outcome measure)

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, SGOT/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 MUGA scan (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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00502411
ID02-336, NCI-2012-01519
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
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Principal Investigator: Peter W. Pisters, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP