Back to results

Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma

Primary Purpose

Soft Tissue Sarcoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Doxorubicin

Radiation Therapy

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Soft Tissue Sarcoma, External Beam Radiotherapy, Radiation Therapy, Extremity and Trunk, EBRT, Sarcoma, Doxorubicin, AD, Hydroxydaunomycin hydrochloride, XRT, RT, Radiotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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.

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.

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doxorubicin + Radiation Therapy

Arm 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00502411

First Posted

July 13, 2007

Last Updated

November 17, 2015

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00502411

Brief Title

Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doxorubicin + Radiation Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

AD, Hydroxydaunomycin hydrochloride

Intervention Description

17.5 mg/m^2 IV bolus infusion, followed by continuous IV infusion on days 1-4.

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Other Intervention Name(s)

XRT, RT, Radiotherapy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Toxicity of Radiation Therapy Plus Low Dose Doxorubicin in Participants with Extremity and Trunk Sarcoma

Description

Time Frame

6 weeks after the start of Doxorubicin

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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, 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter W. Pisters, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma

We'll reach out to this number within 24 hrs