Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
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|ClinicalTrials.gov Identifier: NCT00915005|
Recruitment Status : Active, not recruiting
First Posted : June 5, 2009
Last Update Posted : February 13, 2018
|First Submitted Date ICMJE||June 4, 2009|
|First Posted Date ICMJE||June 5, 2009|
|Last Update Posted Date||February 13, 2018|
|Actual Start Date ICMJE||June 2009|
|Estimated Primary Completion Date||June 2019 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
||Time to development of treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment). [ Time Frame: 3 Years ]|
|Change History||Complete list of historical versions of study NCT00915005 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||Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence|
|Official Title ICMJE||A Bayesian Randomized Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence|
|Brief Summary||The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.|
There are 2 types of radiation treatment being used in this study. One type of treatment is proton therapy. Proton therapy is a type of radiation therapy that uses a beam of proton particles (similar to getting an x-ray) to send radiation inside the body to the tumor. The other type of treatment is Image-Guided Adaptive Photon Therapy (IGAPT). IGAPT is a therapy that uses images to help guide the delivery of photon therapy to the tumor. Both of these types of radiation treatment are believed to help doctors to give a full dose of radiation treatment to the tumor while not damaging as much of the healthy tissue around it.
If you are found to be eligible to take part in this study, you will go through the standard radiation treatment planning procedure, called the "marking session." After the marking session, a standard photon therapy plan (called Intensity Modulated Radiation Therapy, or IMRT) and a proton plan will be developed. If the radiation oncologist thinks that both the photon and proton plans are acceptable, you will then be randomly assigned to 1 of 2 groups. Participants in Group 1 will receive photon therapy. Participants in Group 2 will receive proton therapy.
The first 20 participants will have an equal chance to be assigned to either group. After at least 20 participants have been enrolled and there has been at least 1 occurrence of pneumonitis and/or tumor recurrence in each treatment Group, the risk of pneumonitis and/or tumor recurrence in all previous participants will be evaluated for each treatment Group, and that information will be used to calculate the chances of being assigned to either Group 1 or Group 2. This calculation will be updated after each occurrence of pneumonitis and/or tumor recurrence and after each participant returns for a follow-up visit. Once these calculations are begun, everyone who joins the study from that point on will be more likely to be assigned to the treatment Group that appears to be better in terms of pneumonitis and/or tumor recurrence.
If the tumor is too large and the standard radiation treatment plan created during the marking session is found not to be acceptable, and the radiation oncologist thinks radiation treatment it is necessary, you will still remain on study and be assigned to a third group. If you are assigned to Group 3, you will receive proton or photon treatment at a lower dose level and/or reduced length of radiation.
If you are assigned to Group 2 and your insurance provider denies reimbursement, you may chose not to receive proton therapy and receive photon therapy instead. If you chose to receive photon therapy, you will be in Group 4.
Radiation Therapy Administration:
Both radiation therapy treatments (photon and proton) are given through a radiation machine called an accelerator. The radiation therapy administration process is very similar to the way that a CT scan is performed. You will lay on a table and the treatment machine rotates around you without touching your body. Each daily treatment should take about 20-30 minutes to complete. Most of this time is used to position you correctly before the machine is turned on. The actual time used to give the radiation should take about 3-5 minutes each day.
While you are on this study and if you are in Groups 1 or 2, you will receive a total of 37 radiation treatments. Radiation is given 5 days a week for about 7 1/2 weeks.
If you are in Group 1, you will receive photon radiation treatment in the main hospital.
If you are in Group 2, you will receive proton therapy in the proton treatment center (PTC).
If you are in Group 3, you will receive either photon or proton therapy, whichever your doctor decides is better for you, for 6-7 1/2 weeks. If your doctor decides that photon therapy is better you will receive your treatment in the main hospital. If your doctor decides that proton therapy is better you will receive your treatment in the Proton Therapy Center.
If you are in Group 4, you will receive Photon radiation treatment in the main hospital.
You will receive carboplatin and paclitaxel chemotherapy 1 time a week over 7 weeks. Each treatment will last 3-4 hours. Paclitaxel will be given by vein over 1 hour and carboplatin will be given by vein over 30 minutes. You will receive this chemotherapy combination with radiation therapy, as part of your treatment on this study.
Your chemotherapy may also be decided by your treating medical oncologist as long as the therapy is allowed by the study.
Study Visits During Chemoradiation:
At least 1 time each week for all study participants, you will have study tests performed. During this weekly study visit, the following tests and procedures will be performed:
If the study doctor thinks it is needed, you will have a PET/CT scan performed to check the status of the disease during Week 4 or 5 of treatment.
Length of Study:
You will remain on study as long you are benefiting. You will be taken off study early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to receive the study treatment.
After you have completed chemoradiation, the study staff or study nurse will contact you 1 time each month to ask you about any symptoms you may have until 6 months after chemoradiation. Each phone call should last about 10 minutes.
You will have your first follow-up visit 4-8 weeks after you have completed chemoradiation. You will have additional follow-up visits every 3-4 months for 3 years, every 6 months for the next 2 years, and then 1 time every year after that.
At the first and second follow-up visit the following tests and procedures will be performed:
If the radiation oncologist or medical oncologist thinks it is needed, at the follow-up visits, you will have breathing function tests performed to check your lung function for up to 1 year after the study treatment is complete. For this test, the radiation oncologist, medical oncologist or study nurse will have you breathe into a special machine. The radiation oncologist or medical oncologist will decide how many tests are to be performed each time.
PET/CT and SPECT scans will be performed again at any time the radiation oncologist or medical oncologist thinks they are needed.
Other tests may be performed if the study doctor (radiation oncologist, medical oncologist, surgeon or pulmonologist ) thinks they are needed.
This is an investigational study. Both proton radiotherapy and IGAPT are FDA approved for the treatment of lung cancer.
Up to 250 patients will take part in this multicenter research study. Up to 205 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: Treatment
|Condition ICMJE||Non-Small-Cell Lung Carcinoma|
|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||250|
|Estimated Completion Date||June 2020|
|Estimated Primary Completion Date||June 2019 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 85 Years (Adult, Senior)|
|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||NCT00915005|
|Other Study ID Numbers ICMJE||2008-0133
NCI-2011-01094 ( Registry Identifier: NCI CTRP )
2P01CA021239-29A1 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|PRS Account||M.D. Anderson Cancer Center|
|Verification Date||February 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP