3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00520702|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2007
Last Update Posted : October 5, 2017
|First Submitted Date ICMJE||August 22, 2007|
|First Posted Date ICMJE||August 24, 2007|
|Last Update Posted Date||October 5, 2017|
|Actual Study Start Date ICMJE||August 2007|
|Estimated Primary Completion Date||August 2019 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Time to Treatment Failure [ Time Frame: 3 months after radiation therapy ]
Time to treatment failure defined as from the time of randomization to the development of treatment related pneumonitis (TRP) or local-regional recurrence, whichever occurs first.
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00520702 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy|
|Official Title ICMJE||A Randomized Trial to Compare Time to Common Toxicity Criteria for Adverse Effect (CTC AEC) 3.0 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)|
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 tumor(s). Because it is delivered at different angles, the same amount of radiation that contacts the tumor(s) 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 tumor(s). The difference is that the amount of treatment at each angle is adjusted according to the shape and size of the tumor(s), 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 (SPECT)test 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 tumor(s) 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 tumor(s) in your lung. The CT scan helps the doctor identify (note the difference between) the tumor(s) and the normal surrounding tissue. The planning session helps the radiation doctor decide the target area(s), 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 tumor(s) 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, and/or 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 M.D. Anderson.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Condition ICMJE||Lung Cancer|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||August 2020|
|Estimated Primary Completion Date||August 2019 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00520702|
|Other Study ID Numbers ICMJE||2006-0222
NCI-2012-01595 ( Registry Identifier: NCI CTRP )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Collaborators ICMJE||Not Provided|
|PRS Account||M.D. Anderson Cancer Center|
|Verification Date||October 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP