Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00520702
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2007-08-22
Brief Title:
3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Trial to Compare Time to Common Toxicity Criteria for Adverse Effect CTC AEC 30 Grade 3 Treatment Related Pneumonitis TRP in Patients With Locally Advanced Non-Small Cell Lung Carcinoma NSCLC Receiving Concurrent Chemoradiation Radiation Treated With 3-Dimensional Conformal Radiation Therapy 3D CRT ARM 1 Versus Intensity Modulated Radiation Therapy IMRT ARM 2 Using 4-Dimensional CT Planning and Image Guided Adaptive Radiation Therapy IGART
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Primary Objective
Developing Common Toxicity Criteria CTC 30 grade 3 treatment related pneumonitis TRP or
Developing local-regional recurrence among patients treated with 3D conformal radiation therapy CRT Arm 1 or intensity modulated radiation therapy IMRT Arm 2
Secondary Objectives
To assess and compare the time to develop CTC 30 grade 3 radiation esophagitis in patients with non-small cell lung cancer NSCLC treated in arm 1 and arm 2
To investigate the association of inflammatory cytokines with the time to the development of radiation pneumonitis and outcomes to concurrent chemoradiation between arm 1 and arm 2
To investigate the association of relevant pharmacogenetics biomarkers and gene polymorphisms with the time to the development of radiation pneumonitis and treatment outcomes to concurrent chemoradiation between arm 1 and arm 2
To evaluate image guided adaptive radiation therapy IGART using weekly computed tomography CT on rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery
To compare overall survival progression-free survival median survival time in arm 1 and arm 2
To evaluate the role of functional image of fluorodeoxyglucose-positron emission tomography FDG-PET in assessing and predicting the time to the development of TRP and tumor response
To measure and compare symptom burden over time of the treatment using MD Anderson Symptom Inventory MDASI-Lung in the 2 arms
To determine the impact of comorbid conditions on survival
Developing Common Toxicity Criteria CTC 30 grade 3 treatment related pneumonitis TRP or
Developing local-regional recurrence among patients treated with 3D conformal radiation therapy CRT Arm 1 or intensity modulated radiation therapy IMRT Arm 2
Secondary Objectives
To assess and compare the time to develop CTC 30 grade 3 radiation esophagitis in patients with non-small cell lung cancer NSCLC treated in arm 1 and arm 2
To investigate the association of inflammatory cytokines with the time to the development of radiation pneumonitis and outcomes to concurrent chemoradiation between arm 1 and arm 2
To investigate the association of relevant pharmacogenetics biomarkers and gene polymorphisms with the time to the development of radiation pneumonitis and treatment outcomes to concurrent chemoradiation between arm 1 and arm 2
To evaluate image guided adaptive radiation therapy IGART using weekly computed tomography CT on rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery
To compare overall survival progression-free survival median survival time in arm 1 and arm 2
To evaluate the role of functional image of fluorodeoxyglucose-positron emission tomography FDG-PET in assessing and predicting the time to the development of TRP and tumor response
To measure and compare symptom burden over time of the treatment using MD Anderson Symptom Inventory MDASI-Lung in the 2 arms
To determine the impact of comorbid conditions on survival
Detailed Description:
TRP treatment related pneumonitis is an inflammation irritated or injured tissue of the lungs that occurs as a result of chemotherapy or radiation therapy TRP occurs because both chemotherapy and radiation affect normal lung tissue when tumors are being treated
3D CRT is the current standard of care It delivers radiation to several different angles of the body with center focus on the tumors Because it is delivered at different angles the same amount of radiation that contacts the tumors also contacts normal lung tissue at each angle
IMRT is a new type of radiation therapy It also delivers radiation to several different angles of the body with center focus on the tumors The difference is that the amount of treatment at each angle is adjusted according to the shape and size of the tumors which in turn may decrease radiation exposure to normal lung tissue at each angle Researchers want to find out if intensity modulated radiation therapy IMRT is able to decrease the amount of normal lung that is affected when treating lung cancer
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a physical exam including measurement of your vital signs blood pressure heart rate temperature and breathing rate You will have blood drawn about 1 tablespoon and urine collected for routine tests You will be asked about any other medical problems you may have that could cause the development of TRP You will have tests that include a computed tomography CT scan positron emission tomography PET scan and lung function test A PET scan is a scan that will show cells that take in higher levels of a type of sugar glucose such as cancer cells Before the scan a small dose of a slightly radioactive form of glucose will be injected through a vein The cells that take in higher amounts of glucose will show up better on the scan The scanning process is quite similar to a regular CT scan No new biopsy is needed only the original biopsy will be used for this study
You will have 2 different single photon-emission computed tomography tests SPECTs You will have a lung single-photon emission computerized tomography SPECTtest that will show the area of blood flow in the normal lung You will have a heart single-photon emission computerized tomography SPECT test that will show the areas of blood flow in the heart To perform these single-photon emission computerized tomography SPECT tests you will have a slightly radioactive substance injected into your vein so that images can be seen of the blood flow in the lung and heart This will help the study doctor try to avoid using radiation angles that would go through the normal blood flow area You will also have a biopsy of your tumor tissue To perform a tumor biopsy an area of the body where tumor is present is numbed with anesthetic and a small amount of tumor tissue is withdrawn through a large needle or with forceps a tong-like instrument during an endoscopic viewing of body cavity with a special instrument exam
Researchers will use the results of these tests to learn the stage size and location of the cancer to see if the tumors can be treated by radiation Women who are able to have children must have a blood or urine pregnancy test which will be performed on the same blood or urine that was collected for routine tests To be eligible to take part in this study the pregnancy test must be negative
If you are found to be eligible to take part in this study your radiation doctor will first conduct a planning session You will have a CT scan of your chest and your respiratory breathing motion will be monitored After the scan is done your radiation doctor will evaluate it and make an outline of the tumors in your lung The CT scan helps the doctor identify note the difference between the tumors and the normal surrounding tissue The planning session helps the radiation doctor decide the target areas the best angles to deliver the radiation and the most effective radiation dose which is also intended to decrease radiation to surrounding normal tissues for treatment
If the plan for treatment is considered acceptable for you by the radiation doctor you will then be randomly assigned as in the toss of a coin to 1 of 2 treatment groups Participants in one group will receive 3D CRT Participants in the other group will receive intensity modulated radiation therapy IMRT You will have an equal chance of being in either one of these groups If you are assigned to receive intensity modulated radiation therapy IMRT the total radiation dose to the tumors will be slightly higher than for participants receiving 3D CRT
If the 3D CRT plan for treatment is not considered acceptable for you usually because of a large target area by the radiation doctor you will be treated with IMRT with or without amifostine Amifostine is a drug given as an injection to protect the normal lung and esophagus tissue from radiation side effects and injury Your treating physician will decide if you need amifostine or not based on the size of the tumor tissue and normal tissue in the radiation field the area given radiation during treatment If you need amifostine a nurse will give you the injection about 30 minutes before radiation treatment Your blood pressure will be checked for 15-20 minutes after injection
Participants on this study will be receiving standard chemotherapy given together with radiation therapy The standard chemotherapy usually includes cisplatin carboplatin paclitaxel or docetaxel The chemotherapy is not considered the investigational part of this study
All study participants will receive standard chemotherapy given together with radiation therapy The standard chemotherapy usually includes cisplatin carboplatin paclitaxel andor docetaxel Your chemotherapy doctor will explain the side effects of these chemotherapy drugs to you before you start receiving chemotherapy The chemotherapy is not the investigational part of this clinical trial
Participants in each group will receive a total of 6 ½ weeks of radiation therapy once a day for 5 days a week You will not be treated on the weekends or on a national holiday If the disease gets worse or you experience any intolerable side effects you will be taken off this study
After you have completed therapy on this study you will have follow-up visits The study doctor will check how the disease responded to treatment using the same imaging scans and blood tests about 1 tablespoon each time that were performed during the screening portion of this study These tests will be performed about every 3-4 months after completion of treatment as part of your standard of care
This is an investigational study Both 3D conformal radiation therapy CRT and intensity modulated radiation therapy IMRT are FDA approved for the treatment of cancer Up to 168 patients will take part in this study All will be enrolled at MD Anderson
3D CRT is the current standard of care It delivers radiation to several different angles of the body with center focus on the tumors Because it is delivered at different angles the same amount of radiation that contacts the tumors also contacts normal lung tissue at each angle
IMRT is a new type of radiation therapy It also delivers radiation to several different angles of the body with center focus on the tumors The difference is that the amount of treatment at each angle is adjusted according to the shape and size of the tumors which in turn may decrease radiation exposure to normal lung tissue at each angle Researchers want to find out if intensity modulated radiation therapy IMRT is able to decrease the amount of normal lung that is affected when treating lung cancer
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a physical exam including measurement of your vital signs blood pressure heart rate temperature and breathing rate You will have blood drawn about 1 tablespoon and urine collected for routine tests You will be asked about any other medical problems you may have that could cause the development of TRP You will have tests that include a computed tomography CT scan positron emission tomography PET scan and lung function test A PET scan is a scan that will show cells that take in higher levels of a type of sugar glucose such as cancer cells Before the scan a small dose of a slightly radioactive form of glucose will be injected through a vein The cells that take in higher amounts of glucose will show up better on the scan The scanning process is quite similar to a regular CT scan No new biopsy is needed only the original biopsy will be used for this study
You will have 2 different single photon-emission computed tomography tests SPECTs You will have a lung single-photon emission computerized tomography SPECTtest that will show the area of blood flow in the normal lung You will have a heart single-photon emission computerized tomography SPECT test that will show the areas of blood flow in the heart To perform these single-photon emission computerized tomography SPECT tests you will have a slightly radioactive substance injected into your vein so that images can be seen of the blood flow in the lung and heart This will help the study doctor try to avoid using radiation angles that would go through the normal blood flow area You will also have a biopsy of your tumor tissue To perform a tumor biopsy an area of the body where tumor is present is numbed with anesthetic and a small amount of tumor tissue is withdrawn through a large needle or with forceps a tong-like instrument during an endoscopic viewing of body cavity with a special instrument exam
Researchers will use the results of these tests to learn the stage size and location of the cancer to see if the tumors can be treated by radiation Women who are able to have children must have a blood or urine pregnancy test which will be performed on the same blood or urine that was collected for routine tests To be eligible to take part in this study the pregnancy test must be negative
If you are found to be eligible to take part in this study your radiation doctor will first conduct a planning session You will have a CT scan of your chest and your respiratory breathing motion will be monitored After the scan is done your radiation doctor will evaluate it and make an outline of the tumors in your lung The CT scan helps the doctor identify note the difference between the tumors and the normal surrounding tissue The planning session helps the radiation doctor decide the target areas the best angles to deliver the radiation and the most effective radiation dose which is also intended to decrease radiation to surrounding normal tissues for treatment
If the plan for treatment is considered acceptable for you by the radiation doctor you will then be randomly assigned as in the toss of a coin to 1 of 2 treatment groups Participants in one group will receive 3D CRT Participants in the other group will receive intensity modulated radiation therapy IMRT You will have an equal chance of being in either one of these groups If you are assigned to receive intensity modulated radiation therapy IMRT the total radiation dose to the tumors will be slightly higher than for participants receiving 3D CRT
If the 3D CRT plan for treatment is not considered acceptable for you usually because of a large target area by the radiation doctor you will be treated with IMRT with or without amifostine Amifostine is a drug given as an injection to protect the normal lung and esophagus tissue from radiation side effects and injury Your treating physician will decide if you need amifostine or not based on the size of the tumor tissue and normal tissue in the radiation field the area given radiation during treatment If you need amifostine a nurse will give you the injection about 30 minutes before radiation treatment Your blood pressure will be checked for 15-20 minutes after injection
Participants on this study will be receiving standard chemotherapy given together with radiation therapy The standard chemotherapy usually includes cisplatin carboplatin paclitaxel or docetaxel The chemotherapy is not considered the investigational part of this study
All study participants will receive standard chemotherapy given together with radiation therapy The standard chemotherapy usually includes cisplatin carboplatin paclitaxel andor docetaxel Your chemotherapy doctor will explain the side effects of these chemotherapy drugs to you before you start receiving chemotherapy The chemotherapy is not the investigational part of this clinical trial
Participants in each group will receive a total of 6 ½ weeks of radiation therapy once a day for 5 days a week You will not be treated on the weekends or on a national holiday If the disease gets worse or you experience any intolerable side effects you will be taken off this study
After you have completed therapy on this study you will have follow-up visits The study doctor will check how the disease responded to treatment using the same imaging scans and blood tests about 1 tablespoon each time that were performed during the screening portion of this study These tests will be performed about every 3-4 months after completion of treatment as part of your standard of care
This is an investigational study Both 3D conformal radiation therapy CRT and intensity modulated radiation therapy IMRT are FDA approved for the treatment of cancer Up to 168 patients will take part in this study All will be enrolled at MD 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-2012-01595 | REGISTRY | NCI CTRP | None |