Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502411
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2007-07-13
Brief Title:
Post-Operative Chemoradiation for Extremity Trunk Soft Tissue Sarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 - 612 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 andor 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
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 - 612 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01519 | REGISTRY | NCI CTRP | None |