Trial Outcomes & Findings for PET-Adjusted Intensity Modulated Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II-IV Non-small Cell Lung Cancer (NCT NCT02073968)

Results Overview

Favorable response will be defined as having maximum SUV less than 6.0 on post-treatment PET/CT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Up to 16 weeks after completion of radiation therapy

Results posted on

2024-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) RADIOTHERAPY: Patients undergo PET-adjusted IMRT five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin paclitaxel weekly for 5 weeks during thoracic radiotherapy. OPTIONAL CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of radiotherapy, subjects may receive up to 3 cycles of consolidation carboplatin and paclitaxel.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy and when esophagitis and chemotherapy-induced neuropathy are grade 1 or less, ANC \> 1500, and platelet count \> 100,000, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Age, Continuous	68 years n=35 Participants
Sex: Female, Male Female	16 Participants n=35 Participants
Sex: Female, Male Male	19 Participants n=35 Participants
Region of Enrollment United States	35 participants n=35 Participants

PRIMARY outcome

Timeframe: Up to 16 weeks after completion of radiation therapy

Favorable response will be defined as having maximum SUV less than 6.0 on post-treatment PET/CT.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=30 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Metabolic Response of All Pulmonary Lesions and Thoracic Lymph Nodes	24 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Incidence of grade \>= 2 radiation-induced lung toxicity, scored using Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4, will be presented as frequency and percentages.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Incidence of Grade >= 2 Radiation-induced Lung Toxicity, Scored Using Common Terminology Criteria for Adverse Events (CTCAE), Version (v.) 4	7 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Incidence of grade \>= 3 treatment-related toxicity, scored using CTCAE, v. 4, will be presented as frequency and percentages.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Incidence of Grade >= 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4	30 Participants

SECONDARY outcome

Timeframe: From study registration to date of local or regional disease progression or death, censored at the date of data collection, assessed at 1 year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier survival plots will be produced. The survival probabilities will be presented.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Locoregional Progression-free Survival Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	50 percentage with LRPFS at 1 year

SECONDARY outcome

Timeframe: From study registration to death directly from lung cancer, censored at the date of data collection, up to a maximum of 5 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions A patient will be considered to have died from lung cancer if he or she had evidence of disease progression at any site and no direct evidence of other cause of death. Kaplan-Meier survival plots will be produced.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Lung Cancer Cause-specific Survival	28 months Interval 28.0 to 28.0

SECONDARY outcome

Timeframe: From study registration to death, censored at the date of data collection, assessed at 1 year

Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. Log-rank testing will be used to compare the survival probabilities between categorical predictors. A Cox regression model will be used to estimate the hazard rates for overall survival among the predictor variables.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Overall Survival	74 percentage of patients alive at 1 year

SECONDARY outcome

Timeframe: From study registration to date of disease progression or death, censored at the date of data collection, assessed at 1 year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. Log-rank testing will be used to compare the survival probabilities between categorical predictors. A Cox regression model will be used to estimate the hazard rates for progression free survival among the predictor variables.

Outcome measures

Outcome measures
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 Participants RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Progression-free Survival Assessed Using the RECIST Criteria	26 percentage of patients w/ PFS at 1 year

Adverse Events

Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)

Serious events: 15 serious events

Other events: 35 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 participants at risk RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Metabolism and nutrition disorders Dehydration	11.4% 4/35 • Number of events 4 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Skin and subcutaneous tissue disorders Dermatitis	5.7% 2/35 • Number of events 2 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Gastrointestinal disorders Dysphagia	5.7% 2/35 • Number of events 2 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Gastrointestinal disorders Nausea	5.7% 2/35 • Number of events 2 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.7% 2/35 • Number of events 2 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/35 • Number of events 1 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
General disorders Fatigue	5.7% 2/35 • Number of events 2 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.

Other adverse events

Other adverse events
Measure	Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) n=35 participants at risk RADIOTHERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin IV over 3 hours and paclitaxel IV over 1 hour once weekly for 6 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. Carboplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo PET-adjusted IMRT Paclitaxel: Given IV Positron Emission Tomography: Undergo PET-adjusted IMRT
Gastrointestinal disorders Anorexia	40.0% 14/35 • Number of events 14 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Gastrointestinal disorders Constipation	22.9% 8/35 • Number of events 8 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Respiratory, thoracic and mediastinal disorders Cough	71.4% 25/35 • Number of events 25 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Skin and subcutaneous tissue disorders Dermatitis	54.3% 19/35 • Number of events 19 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.
Gastrointestinal disorders Dysphagia	68.6% 24/35 • Number of events 24 • Median follow-up time is 5.5 months for the entire cohort and 23.8 months for surviving patients. Adverse events were scored using Common Terminology Criteria for Adverse Events version 4.0 at each study visit. Adverse events occurring within 90 days of radiation therapy completion were categorized as acute toxicities, and subsequent adverse events were categorized as late toxicities.

Additional Information

Dr. Nitin Ohri

Montefiore Medical Center / Albert Einstein College of Medicine

Phone: 718-920-7750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place