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 weekly until completion of radiation treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly until completion of radiation treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly until completion of radiation treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly until completion of radiation treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Establish the maximum tolerated dose of radiotherapy in terms of Gy (RBE)/fraction using hypofractionated proton therapy concurrently with chemotherapy.