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A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma


Phase 1
N/A
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma

Thank you

Trial Information

A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma


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.


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 condit

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

7 Years

Safety Issue:

Yes

Principal Investigator

Peter W. Pisters, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID02-336

NCT ID:

NCT00502411

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Soft Tissue Sarcoma
  • Soft Tissue Sarcoma
  • External Beam Radiotherapy
  • Radiation Therapy
  • Extremity and Trunk
  • EBRT
  • Sarcoma
  • Doxorubicin
  • AD
  • Hydroxydaunomycin hydrochloride
  • XRT
  • RT
  • Radiotherapy
  • Sarcoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030