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Photon Beam Therapy
Photon vs Proton Radiation for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Led By Zhongxing Liao
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically proven diagnosis of non-small cell lung cancer
Peripheral neuropathy =< grade 1 at the time of registration
Must not have
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Prior systemic chemotherapy for the study cancer, if more than 4 cycles of induction chemotherapy or more than 6 months of targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to end of follow-up
Awards & highlights
Summary
This trial is comparing two types of radiation therapy to see which is more effective in treating patients with stage II-IIIB non-small cell lung cancer- proton chemoradiotherapy versus photon chemoradiotherapy.
Who is the study for?
This trial is for adults with stage II-IIIB non-small cell lung cancer that can't be surgically removed. They should have acceptable organ function, no severe illnesses, and not have had certain previous cancer treatments. Women who can bear children must test negative for pregnancy and all participants must agree to use contraception.Check my eligibility
What is being tested?
The study compares two types of radiation therapy (photon vs proton) combined with chemotherapy drugs like paclitaxel and carboplatin to see which is more effective in treating non-operable lung cancer without causing much damage to healthy tissue.See study design
What are the potential side effects?
Possible side effects include fatigue, skin reactions at the treatment site, nausea, hair loss from chemotherapy drugs, as well as potential risks associated with radiation such as inflammation of surrounding organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer diagnosis was confirmed through lab tests.
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My nerve damage symptoms are mild or not present.
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My kidney function is normal, based on recent tests.
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My cancer is at stage II, IIIA, or IIIB and cannot be removed by surgery.
Select...
My lung cancer has spread to nearby lymph nodes but the primary tumor can't be found.
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I have chosen not to undergo surgery for my condition.
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My white blood cell count is healthy.
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I have fluid in my chest that is not caused by cancer.
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My cancer returned after surgery and I am eligible for combined chemotherapy and radiation.
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My cancer has not spread to distant parts of my body.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant and willing to use contraception if of childbearing potential.
Select...
I've had more than 4 cycles of chemo or over 6 months of targeted therapy for my cancer.
Select...
I've had radiation in the same area as my current cancer.
Select...
I have had lung cancer before, regardless of the type or treatment.
Select...
I have lost more than 10% of my weight without trying in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration until death or last follow-up; analysis occurs after 390 deaths have been reported
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration until death or last follow-up; analysis occurs after 390 deaths have been reported
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Adverse events
Progression-free survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (proton beam radiation therapy and chemotherapy)Experimental Treatment9 Interventions
Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* and carboplatin*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy.
CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.
Group II: Arm I (photon beam radiation therapy and chemotherapy)Active Control9 Interventions
Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* IV over 1 hour and carboplatin* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy.
CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Etoposide
FDA approved
Pemetrexed
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Durvalumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,071 Total Patients Enrolled
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,596 Total Patients Enrolled
NRG OncologyOTHER
232 Previous Clinical Trials
100,419 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and willing to use contraception if of childbearing potential.My lung cancer diagnosis was confirmed through lab tests.I've had radiation in the same area as my current cancer.My nerve damage symptoms are mild or not present.I am a woman who can have children and I have a negative pregnancy test from the last 14 days.Your hemoglobin level is at least 9.0 grams per deciliter in a blood test taken within the last 30 days.The levels of certain liver enzymes in your blood were checked within the last month.I've had more than 4 cycles of chemo or over 6 months of targeted therapy for my cancer.Your total bilirubin level has to be less than or equal to 1.5 in the 30 days before you join the study.My kidney function is normal, based on recent tests.My cancer is at stage II, IIIA, or IIIB and cannot be removed by surgery.My lung cancer has spread to nearby lymph nodes but the primary tumor can't be found.I have chosen not to undergo surgery for my condition.I have been mostly active and able to carry on all pre-disease activities without restriction recently.My white blood cell count is healthy.You have a serious, ongoing health problem.I have fluid in my chest that is not caused by cancer.My cancer returned after surgery and I am eligible for combined chemotherapy and radiation.I've had up to 4 rounds of chemo or 6 months of targeted therapy.I have been cancer-free for at least 3 years from a previous cancer.I have had lung cancer before, regardless of the type or treatment.I have lost more than 10% of my weight without trying in the last month.You can exhale a certain amount of air in one second, and it's more than a specific volume or percentage.Your platelet count is at least 100,000 cells/mm^3 within the last 30 days before joining the study.My cancer has not spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (proton beam radiation therapy and chemotherapy)
- Group 2: Arm I (photon beam radiation therapy and chemotherapy)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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