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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.
Must not have
Prior radiotherapy to thoracic area.
Evidence of distant metastasis (M1) involvement.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years and 5 years
Awards & highlights

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 below
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A specialist has determined I cannot have surgery for my condition.
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My cancer is at stage II or III according to AJCC 7th Ed.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my chest area before.
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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years and 5 years for reporting.

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

Concurrent Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01770418 — Phase 1 & 2
Lung Cancer Research Study Groups: Proton Radiotherapy with Chemotherapy
Lung Cancer Clinical Trial 2023: Concurrent Chemotherapy Highlights & Side Effects. Trial Name: NCT01770418 — Phase 1 & 2
Concurrent Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01770418 — Phase 1 & 2
Lung Cancer Patient Testimony for trial: Trial Name: NCT01770418 — Phase 1 & 2
~17 spots leftby Jan 2038