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Phase 2 N=138 Randomized Treatment

Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy for Stage III Non-small Cell Lung Cancer

Stage III Lung Non-Small Cell Cancer AJCC v7 · Stage IIIA Lung Non-Small Cell Cancer AJCC v7 · Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Enrolled (actual)
138
Serious AEs
33.1%
Results posted
Apr 2026
Primary outcome: Primary: Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG) — 59.5; 54.6 percentage of participants — p=0.6585

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
18F-Fluoromisonidazole (Drug); Carboplatin (Drug); Computed Tomography (Procedure); External Beam Radiation Therapy (Radiation); Fludeoxyglucose F-18 (Drug); Image-Guided Adaptive Radiation Therapy (Radiation); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Positron Emission Tomography (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Aug 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG)
59.5; 54.6 0.6585
PRIMARY
Relative Change in SUVpeak From the Baseline to the During-treatment Fludeoxyglucose F 18 (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) to LRPF With a 2-year Follow up. (ECOG-ACRIN)
-38.2; -40.6 0.43
SECONDARY
Percentage of Participants With Local-regional Progression (NRG)
27.5; 32.5 0.8313
SECONDARY
Percentage of Participants Alive (Overall Survival) (NRG)
64.7; 56.3 0.7950
SECONDARY
Percentage of Participants Alive Without Progression (Progression-free Survival) (NRG)
27.6; 33.9 0.4590
SECONDARY
Percentage of Participants With Death Due to Lung Cancer (NRG)
30.3; 36.2 0.6863
SECONDARY
Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG)
5.3; 6.9; 5.3; 1.4 1.0000
SECONDARY
Percentage of Participants With Grade 3+ Esophagitis, Pericardial Effusion, and Any Cardiac Adverse Events at Any Time (NRG)
7.1; 3.8; 0; 0; 2.4; 1.3 0.4133
SECONDARY
Baseline 18F-fluoromisonidazole (FMISO) Uptake (Tumor-to-blood Pool Ratio) Measures Association With LRPF 2-years Post Registration (ECOG-ACRIN)
1.60; 1.48; 1.68; 2.73; 2.50; 2.88 0.7997
SECONDARY
Baseline 18F-fluoromisonidazole (FMISO) Tumor Hypoxic Volume Association With LRPF 2-years Post Registration (ECOG-ACRIN)
29.59; 9.65; 42.40 0.4235
SECONDARY
Relative Change in SUV Peak From the Baseline to the During-treatment FDG PET/CT Prediction of the Differential Benefit of the Adaptive Therapy (ECOG-ACRIN)
-34.71; -44.13; -29.21; -42.62; -34.43; -46.45
SECONDARY
SUVmax at Baseline Prediction of OS and Optimal Threshold (ECOG-ACRIN)
19.85; 21.00; 19.16; 17.66; 14.78; 19.12
SECONDARY
FDG ΔSUVmax, From Baseline to the During-treatment FDG PET/CT, to Predict OS and Optimal Threshold (ECOG-ACRIN)
-38.68; -39.13; -38.42; -41.11; -33.75; -44.56
SECONDARY
ΔSUVpeak Prediction of Overall Survival, Progression Free Survival, and Lung Cancer Cause-specific Survival (ECOG-ACRIN)
-34.71; -44.13; -29.21; -42.62; -34.43; -46.45
SECONDARY
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
-34.71; -44.13; -29.21; -42.62; -34.43; -46.45
SECONDARY
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
-34.27; -33.15; -34.92; 53.59; -21.60; 88.79
SECONDARY
FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Overall Survival and Optimal Threshold (ECOG-ACRIN)
19.88; 12.42; 24.36; 34.76; 8.27; 52.43
SECONDARY
FDG SUVmax @ Baseline FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
19.66; 20.55; 19.22; 17.42; 14.57; 19.06
SECONDARY
FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
-41.94; -39.55; -43.14; -38.87; -32.87; -41.95
SECONDARY
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
-39.15; -42.35; -37.55; -40.34; -34.88; -43.15
SECONDARY
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
-33.56; -23.02; -38.83; 67.91; -28.55; 117.38
SECONDARY
FMISO Hypoxic Tumor Volume (HV) @Baseline, to Predict Lung Cancer Cause-specific Survival and Optimal Threshold (ECOG-ACRIN)
18.08; 12.42; 20.91; 36.98; 8.27; 58.52
SECONDARY
FDG SUVmax @ Baseline FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
21.44; 22.10; 20.96; 17.82; 15.86; 18.82
SECONDARY
FDG ΔSUVmax From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
-42.29; -37.85; -45.40; -39.86; -35.36; -42.01
SECONDARY
FDG ΔSUVpeak From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
-46.89; -45.48; -47.87; -38.47; -36.44; -39.44
SECONDARY
FDG ΔMTV From Baseline to the During-treatment FDG PET/CT, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
-31.41; -34.95; -28.93; 32.55; -23.96; 59.42
SECONDARY
FMISO Hypoxic Tumor Volume @Baseline, to Predict Local-Regional Progression-Free and Optimal Threshold (ECOG-ACRIN)
10.87; 14.82; 8.24; 34.79; 8.18; 51.72

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.

Eligibility Criteria

Inclusion Criteria

  • Patients must have FDG-avid (maximum SUV >= 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven non-small cell lung cancer
  • Patients must be clinical American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team, involving evaluation by at least 1 thoracic surgeon within 8 weeks prior to registration; Note: For patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and a medical oncologist, or pulmonologist
  • Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned
  • History/physical examination, including documentation of weight, within 2 weeks prior to registration
  • FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration
  • CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration
  • CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
  • Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 Liter or >= 50% predicted without bronchodilator
  • Zubrod performance status 0-1
  • Able to tolerate PET/CT imaging required to be performed at an American College of Radiology (ACR) Imaging Core Laboratory (Lab) qualified facility
  • Absolute neutrophil count (ANC) >= 1, 500 cells/mm^3 (within 2 weeks prior to registration on study)
  • Platelets >= 100, 000 cells/mm^3 (within 2 weeks prior to registration on study)
  • Hemoglobin (Hgb) >= 10.0 g/dL (note: the use of transfusion or other intervention to achieve Hgb >= 10.0 g/dL is acceptable) (within 2 weeks prior to registration on study)
  • Serum creatinine within normal institutional limits or a creatinine clearance >= 60 ml/min within 2 weeks prior to registration
  • Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
  • The patient must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • Patients with any component of small cell lung carcinoma are excluded
  • Patients with evidence of a malignant pleural or pericardial effusion are excluded
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immun
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01507428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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