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Arm II (experimental chemoradiotherapy) for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Feng-Ming (Spring) P Kong
Research Sponsored by National Cancer Institute (NCI)
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 randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT)-guided radiation therapy works compared to standard radiation therapy in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans, to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor and cause less damage to healthy tissue.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Local-regional, progression-free (LRPF) rate (National Surgical Adjuvant Breast and Bowel Project [NSABP], Radiation Therapy Oncology Group [RTOG], Gynecologic Oncology Group [GOG] [NRG])
Relative change in standard uptake volume (SUV) peak from the baseline to the during-treatment fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) to LRPF (ECOG-ACRIN)
Secondary outcome measures
Baseline 18F-fluoromisonidazole (FMISO) uptake (tumor-to-blood pool ratio) association with LRPF (i.e. the assessment of using baseline FMISO-PET uptake as a prognostic marker) (ECOG-ACRIN)
Body Weight Changes
Change of peak SUVs for FDG from pre- to during-treatment (ECOG-ACRIN)
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (experimental chemoradiotherapy)Experimental Treatment8 Interventions
Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I.
Group II: Arm I (standard chemoradiotherapy)Active Control8 Interventions
Patients undergo radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FDG-PET/CT imaging between fractions 18 and 19.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorine F-18
Not yet FDA approved
Computed Tomography
2017
Completed Phase 2
~2720
Paclitaxel
FDA approved
Misonidazole
Not yet FDA approved
Carboplatin
FDA approved
Image-Guided Adaptive Radiation Therapy
2015
Completed Early Phase 1
~50
Positron Emission Tomography
2008
Completed Phase 2
~2210

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
232 Previous Clinical Trials
101,051 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,703 Previous Clinical Trials
40,931,612 Total Patients Enrolled
Feng-Ming (Spring) P KongPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer
2012. "Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01507428.
All > Lung > Sclc
~10 spots leftby May 2025
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