Trial Outcomes & Findings for Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer (NCT NCT00124618)
NCT ID: NCT00124618
Last Updated: 2016-07-06
Results Overview
Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
COMPLETED
PHASE2
58 participants
From baseline to 11 months.
2016-07-06
Participant Flow
This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an North Central Cancer Treatment Group (NCCTG) audit. This analysis includes all 58 patients, with the exception of Overall Survival (OS), Time to Progression (TTP), and response which remove the ineligible patient.
Participant milestones
| Measure |
Cetuximab/Radiation
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cetuximab/Radiation
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab/Radiation
n=58 Participants
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Age, Customized
Median Age in years (Range)
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 11 months.Population: This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an NCCTG audit. This analysis includes all 57 patients. Forty of 57 patients (70%) reached the 11-month survival primary point.
Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
Outcome measures
| Measure |
Cetuximab/Radiation
n=57 Participants
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
11-month Survival Rate
|
70 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to up to 3 yearsSurvival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Cetuximab/Radiation
n=57 Participants
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Survival Time
|
15.1 months
Interval 13.1 to 19.3
|
SECONDARY outcome
Timeframe: From Baseline to up to 3 yearsTime to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Outcome measures
| Measure |
Cetuximab/Radiation
n=57 Participants
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Time to Disease Progression
|
7.2 months
Interval 5.8 to 8.6
|
SECONDARY outcome
Timeframe: Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registrationA confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Outcome measures
| Measure |
Cetuximab/Radiation
n=57 Participants
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Tumor Response (Complete and Partial)
Number of patients with Partial Response (PR)
|
15 participants
|
|
Tumor Response (Complete and Partial)
Number of patients with Complete Response (CR)
|
0 participants
|
Adverse Events
Cetuximab/Radiation
Serious adverse events
| Measure |
Cetuximab/Radiation
n=58 participants at risk
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/58 • Number of events 1
|
Other adverse events
| Measure |
Cetuximab/Radiation
n=58 participants at risk
Cetuximab (C225) and Radiation therapy
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
5.2%
3/58 • Number of events 4
|
|
Cardiac disorders
Arrhythmia
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
1.7%
1/58 • Number of events 2
|
|
Eye disorders
Extraocular muscle paresis
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
12.1%
7/58 • Number of events 18
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
11/58 • Number of events 30
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
4/58 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
17.2%
10/58 • Number of events 19
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
32.8%
19/58 • Number of events 47
|
|
Gastrointestinal disorders
Esophageal mucositis
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
5.2%
3/58 • Number of events 4
|
|
Gastrointestinal disorders
Esophageal stenosis
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
5.2%
3/58 • Number of events 4
|
|
Gastrointestinal disorders
Mucositis oral
|
31.0%
18/58 • Number of events 46
|
|
Gastrointestinal disorders
Nausea
|
43.1%
25/58 • Number of events 72
|
|
Gastrointestinal disorders
Oral pain
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
32.8%
19/58 • Number of events 31
|
|
General disorders
Chills
|
3.4%
2/58 • Number of events 4
|
|
General disorders
Death NOS
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Disease progression
|
3.4%
2/58 • Number of events 2
|
|
General disorders
Fatigue
|
41.4%
24/58 • Number of events 68
|
|
General disorders
Pain
|
3.4%
2/58 • Number of events 7
|
|
Immune system disorders
Hypersensitivity
|
6.9%
4/58 • Number of events 5
|
|
Infections and infestations
Nail infection
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
20.7%
12/58 • Number of events 17
|
|
Infections and infestations
Skin infection
|
1.7%
1/58 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/58 • Number of events 2
|
|
Injury, poisoning and procedural complications
Aortic injury
|
1.7%
1/58 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
5.2%
3/58 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/58 • Number of events 1
|
|
Investigations
INR increased
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
20.7%
12/58 • Number of events 24
|
|
Investigations
Lymphocyte count decreased
|
8.6%
5/58 • Number of events 11
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Platelet count decreased
|
8.6%
5/58 • Number of events 16
|
|
Investigations
Weight loss
|
3.4%
2/58 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
22.4%
13/58 • Number of events 48
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
5.2%
3/58 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
12.1%
7/58 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
37.9%
22/58 • Number of events 64
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
3.4%
2/58 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.7%
1/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
5.2%
3/58 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
1/58 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.4%
2/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.4%
2/58 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
3/58 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/58 • Number of events 2
|
|
Nervous system disorders
Ataxia
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.9%
4/58 • Number of events 5
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.1%
7/58 • Number of events 7
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
1/58 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
3.4%
2/58 • Number of events 2
|
|
Psychiatric disorders
Depression
|
3.4%
2/58 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
3.4%
2/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
5/58 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.7%
12/58 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
13.8%
8/58 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
31.0%
18/58 • Number of events 56
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.7%
1/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.9%
4/58 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
3/58 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
20.7%
12/58 • Number of events 38
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
3/58 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.7%
1/58 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
86.2%
50/58 • Number of events 258
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.4%
2/58 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.7%
1/58 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
1.7%
1/58 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place