Your session is about to expire
← Back to Search
Chemotherapy
Intense Radiation + Chemotherapy for Lung Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be evaluated by a thoracic surgeon, pulmonologist or medical oncologist and deemed medically or surgically unacceptable for resection.
AJCC (American Joint Committee on Cancer) 7th Ed. clinical stage II-III.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years and 5 years
Awards & highlights
Study Summary
This trial is testing if a shorter, more intense course of radiation therapy can be as effective as the standard longer course of radiation therapy for cancer patients.
Who is the study for?
This trial is for adults with stage II-III non-small cell lung cancer who can't have surgery. They should be in good physical condition, not pregnant, willing to use contraception, and haven't lost a lot of weight recently. No prior chest radiation or evidence of cancer spread far from the lung is allowed.Check my eligibility
What is being tested?
The study tests if giving higher daily doses of proton radiation therapy over fewer days (hypofractionation) combined with standard chemotherapy works better for treating non-small cell lung cancer than current methods.See study design
What are the potential side effects?
Possible side effects include skin reactions at the treatment site, fatigue, nausea, difficulty swallowing due to esophagitis, shortness of breath from inflammation in the lungs (pneumonitis), and other typical chemotherapy-related side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
A specialist has determined I cannot have surgery for my condition.
Select...
My cancer is at stage II or III according to AJCC 7th Ed.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Establish the maximum tolerated dose of radiotherapy in terms of Gy (RBE)/fraction using hypofractionated proton therapy concurrently with chemotherapy.
Phase II: Determine the percentage of patients that survive at least 12 months
Secondary outcome measures
Analyze for disease control and overall survival.
Assess acute and late adverse events of concurrent chemotherapy with hypofractionated proton therapy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Proton Radiotherapy with ChemotherapyExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
41,102 Total Patients Enrolled
Brad Hoppe, MDStudy ChairProton Collaborative Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lab test results must be from within the 4 weeks before you join the study.Your white blood cell count must be higher than 1,800 cells/mm3.You have at least 100,000 platelets per cubic millimeter of blood.Your liver enzymes (AST/SGOT and ALT/SGPT) must be less than 2.5 times the normal limit.I have had radiation therapy to my chest area before.I have lost more than 10% of my weight without trying in the last month.I am not pregnant or breastfeeding and willing to use contraception during and for 12 months after the study.My cancer is at stage II or III according to AJCC 7th Ed.My lung function test shows I can exhale more than 0.75 liters of air in a second.A specialist has determined I cannot have surgery for my condition.My lung cancer was confirmed by a lab test within the last 12 weeks, or within 6 months if I had chemotherapy.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 8 weeks.I am 18 years old or older.I had a chest surgery over 3 weeks ago or I haven't had one.My cancer has spread to distant parts of my body.My hemoglobin level is at least 10 g/dl, possibly after receiving treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Radiotherapy with Chemotherapy
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.
Lung Cancer Patient Testimony for trial: Trial Name: NCT01770418 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this medical experiment still open?
"The data found on clinicaltrials.gov indicates that this trial is no longer recruiting participants, having been posted in March 2013 and lastly edited in October 2021. Despite the conclusion of this study, there are presently 1904 other trials offering enrollment opportunities for volunteers."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
ProCure Proton Therapy Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I'm not sure but I've done chemo therapy 4 times since being diagnosed with lung cancer this past January 2023. My tumor has shrunk from 10cm to 3cm. I'm continuing now on immunotherapy. I think I'm doing good. Won't get another scan until September 2023. Not sure what to do. I just want this tumor in my chest all gone.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger