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Alkylating agents
Chemotherapy + Proton Beam Therapy for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Terence T. Sio, M.D., M.S.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing different doses of proton beam therapy for people with lung cancer that cannot be removed by surgery.
Who is the study for?
This trial is for adults with stage II-III non-small cell lung cancer that can't be surgically removed. Participants must have adequate blood counts, organ function, and a performance status indicating they are relatively active. They should not have significant weight loss recently, any distant metastases, or severe diseases that could affect the study's outcomes.Check my eligibility
What is being tested?
The trial is testing how well a combination of platinum-based chemotherapy drugs (like carboplatin and cisplatin) works alongside proton beam radiation therapy to treat lung cancer. The goal is to see if this combo is more effective in stopping cancer growth compared to current treatments.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, hair loss from chemotherapy; skin redness and difficulty swallowing from radiation therapy; as well as potential low blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Distant metastasis
Incidence of adverse events
Local-regional failure
+1 moreOther outcome measures
Quality of life post treatment
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm C (platinum doublet chemotherapy, higher dose PBT)Experimental Treatment5 Interventions
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (platinum doublet chemotherapy, lower dose PBT)Experimental Treatment8 Interventions
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~5250
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,107 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,834 Total Patients Enrolled
Terence T. Sio, M.D., M.S.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have lost more than 10% of your body weight in the last 3 months.Cancer has spread to other parts of the body.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.Your white blood cell count is higher than 3.0 x 10^9 per liter.Your hemoglobin level is at least 9 grams per deciliter.You had radiation treatment to your chest that would overlap with the proton therapy area.You have a health condition that is not under control, such as an ongoing infection, heart problems, or mental health issues that could make it hard for you to follow the study rules.You are able to perform everyday activities without any restrictions or only have some restrictions in physically strenuous activity.Your absolute neutrophil count is equal to or greater than 1.5 x 10^9 per liter.You are currently taking any experimental medication for your main cancer.You currently have another type of cancer that is still growing or causing problems.You had a heart attack within the last 6 months, or you have heart failure that requires ongoing medication for serious heart rhythm problems.Your non-small cell lung cancer cannot be removed with surgery or it is not safe for you to have surgery.Women who are currently breastfeeding.You have had chemotherapy for lung cancer in the last 6 months.You are able to receive chemotherapy and radiation therapy with the goal of curing the cancer.You need to have a biopsy to confirm that you have non-small cell lung cancer.You can breathe out a certain amount of air in one second.You had surgery for stage 2-3 non-small cell lung cancer, and it has come back, or you had most of stage 2-3 non-small cell lung cancer removed during surgery.Your platelet count is more than 100 billion per liter.Your kidney function, as measured by serum creatinine, is within a certain range.Your bilirubin level in the blood is within a certain normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (platinum doublet chemotherapy, lower dose PBT)
- Group 2: Arm C (platinum doublet chemotherapy, higher dose PBT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what types of cancer is Chemotherapy and Proton Beam Therapy 66 Gy most often the chosen method of treatment?
"melanoma patients are often prescribed Chemotherapy and Proton Beam Therapy 66 Gy. However, this treatment method is not exclusive to melanoma and can also be applied to neoplasm metastasis, lymphoma, non-hodgkin, and advanced sarcoma."
Answered by AI
Has the FDA greenlit Chemotherapy and Proton Beam Therapy 66 Gy?
"Chemotherapy and Proton Beam Therapy 66 Gy have been evaluated for safety in Phase 2 trials. While there is some evidence supporting its safety, more data is needed to support efficacy."
Answered by AI
Are participants being sought for this experiment at the moment?
"The trial, which was originally posted on 7/31/2017 and updated on 11/9/2022, is still recruiting patients according to the information available on clinicaltrials.gov."
Answered by AI
Are there other ongoing investigations assessing the efficacy of Chemotherapy and Proton Beam Therapy 66 Gy?
"At the moment, 1228 studies are underway that focus on chemotherapy and proton beam therapy 66 Gy. Out of those 342 studies, 342 are phase 3 clinical trials. The many trials for Chemotherapy and Proton Beam Therapy 66 Gy largely take place in Shanghai but there are 67004 locations running these types of experiments."
Answered by AI
How many people are being included in this test?
"Yes, as of 11/9/2022, this clinical trial is still admitting patients. The original posting date was 7/31/2017. Up to 120 people from 2 different locations can participate in the trial."
Answered by AI
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