Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495170
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2007-06-28
Brief Title:
Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIAB Non-Small Cell Lung Cancer NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIAB Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2019-01
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 proton radiotherapy given with standard chemotherapy such as paclitaxel and carboplatin can help to control locally advanced NSCLC The safety of this treatment will also be studied
Detailed Description:
A proton beam is made up of charged particles that have a well-defined range of penetration into tissues How deep it can penetrate is decided by both the beams energy and the density of the tissue through which it passes As the proton beam penetrates the body the particles slow down and the beam deposits its dose sharply near the end of its range This is a phenomenon known as the Bragg peak By adjusting the Bragg peak the doctor can deliver a full localized uniform dose of energy to the treatment site while sparing the surrounding normal tissues The proton beam is ideal for treatments where organ preservation is very important such as lung cancer
If you are found to be eligible to take part in this study you will receive 37 treatments of proton radiotherapy Monday through Friday for 7 12 weeks During the treatment you will lie still on a table for about 30-45 minutes per day in the same position The proton machine will deliver the dose according to the plan designed by the physician and controlled by a computer You will not feel see or smell anything during the proton beam delivery While on study you will also be receiving weekly standard low-dose chemotherapy possibly followed by full-dose chemotherapy
During the treatment you will be seen by a doctor and research nurse once a week to evaluate possible side effects You will have a physical exam and you will have a medical history About 2 teaspoons of blood will be drawn for routine tests
You will be taken off study early if the disease gets worse or intolerable side effects occur After finishing the treatment 6 week follow up is recommended after completion of radiotherapy then required every 3 months 1 month for 2 years then every 6 months 1 month for 3 years and then once a year for 2 years You will have imaging tests chest CT or positron emission computed tomography PET scan and routine blood tests about 2 teaspoons at the follow-up visits
This is an investigational study Proton radiotherapy is FDA approved for the treatment of lung cancer A total of 65 patients will be take part in this study All will be enrolled at MD Anderson
If you are found to be eligible to take part in this study you will receive 37 treatments of proton radiotherapy Monday through Friday for 7 12 weeks During the treatment you will lie still on a table for about 30-45 minutes per day in the same position The proton machine will deliver the dose according to the plan designed by the physician and controlled by a computer You will not feel see or smell anything during the proton beam delivery While on study you will also be receiving weekly standard low-dose chemotherapy possibly followed by full-dose chemotherapy
During the treatment you will be seen by a doctor and research nurse once a week to evaluate possible side effects You will have a physical exam and you will have a medical history About 2 teaspoons of blood will be drawn for routine tests
You will be taken off study early if the disease gets worse or intolerable side effects occur After finishing the treatment 6 week follow up is recommended after completion of radiotherapy then required every 3 months 1 month for 2 years then every 6 months 1 month for 3 years and then once a year for 2 years You will have imaging tests chest CT or positron emission computed tomography PET scan and routine blood tests about 2 teaspoons at the follow-up visits
This is an investigational study Proton radiotherapy is FDA approved for the treatment of lung cancer A total of 65 patients will be take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2012-01504 | REGISTRY | NCI CTRP | None |