Trial Outcomes & Findings for Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer (NCT NCT00096226)
NCT ID: NCT00096226
Last Updated: 2019-09-18
Results Overview
If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
Chemoradiation, Surgery, Chemotherapy
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Eligible
|
57
|
|
Overall Study
Eligible and Underwent Surgery
|
37
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Chemoradiation, Surgery, Chemotherapy
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Overall Study
Ineligible
|
2
|
|
Overall Study
Protocol treatment not started
|
1
|
Baseline Characteristics
Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 Participants
Chemoradiation, surgery, chemotherapy
carboplatin
paclitaxel
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.Population: Eligible patients who had adequate pathologic information of mediastinal nodal status.
If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=43 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Mediastinal Nodal Clearance Rate
|
27 participants
|
SECONDARY outcome
Timeframe: At time of surgery (16-18 weeks)Population: Eligible patients who underwent surgery
Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=37 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
SECONDARY outcome
Timeframe: From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)Population: Eligible patients who underwent surgery
The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=37 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery
|
21.6 percentage of participants
Interval 9.8 to 38.2
|
SECONDARY outcome
Timeframe: At time of surgery (16-18 weeks)Population: Eligible patients
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Percentage of Patients Able to Undergo Surgical Resection
|
64.9 percentage of participants
Interval 51.1 to 77.1
|
SECONDARY outcome
Timeframe: At time of surgery (16-18 weeks)Population: Eligible patients who underwent surgery
An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=37 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Distribution of R0, R1, and R2 Resections After Chemotherapy
R0
|
75.7 percentage of participants
Interval 61.9 to 89.5
|
|
Distribution of R0, R1, and R2 Resections After Chemotherapy
R1
|
24.3 percentage of participants
Interval 11.8 to 41.2
|
|
Distribution of R0, R1, and R2 Resections After Chemotherapy
R2
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: Eligible patients
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Overall Survival at Two Years
|
53.8 percentage of participants
Interval 40.0 to 65.8
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: Eligible patients
Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Progression-free Survival at Two Years
|
32.7 percentage of participants
Interval 20.9 to 45.0
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up, a maximum of 64.3 monthsPopulation: Eligible patients
The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.
Outcome measures
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 Participants
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Distribution of Highest Grade Adverse Event
Grade 3
|
49.1 percentage of participants
Interval 35.6 to 62.7
|
|
Distribution of Highest Grade Adverse Event
Grade 4
|
19.3 percentage of participants
Interval 10.1 to 31.9
|
|
Distribution of Highest Grade Adverse Event
Grade 5
|
1.8 percentage of participants
Interval 0.0 to 9.4
|
Adverse Events
Chemoradiation, Surgery, Chemotherapy
Serious events: 19 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 participants at risk
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Blood and lymphatic system disorders
Blood/bone marrow - Other
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Arrhythmia NOS
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Myocardial ischemia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Ocular/visual - Other
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal distention
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophagitis NOS
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pyrexia
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Rigors
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Hypersensitivity NOS
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Serum sickness
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Anal infection NOS
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Gingival infection
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Syncope
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.5%
2/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged chest tube drainage or air leak after pulmonary resection
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.8%
1/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension NOS
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Chemoradiation, Surgery, Chemotherapy
n=57 participants at risk
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|
|---|---|
|
Blood and lymphatic system disorders
Blood/bone marrow - Other
|
12.3%
7/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
38/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Pericardial effusion
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
19.3%
11/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Vision blurred
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
43.9%
25/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea NOS
|
24.6%
14/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
22.8%
13/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
57.9%
33/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal pain
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophagitis NOS
|
56.1%
32/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastritis NOS
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic): Esophagus
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
61.4%
35/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
22.8%
13/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
33.3%
19/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema: limb
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
93.0%
53/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain - Other
|
19.3%
11/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pyrexia
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Rigors
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Hypersensitivity NOS
|
12.3%
7/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
52.6%
30/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Radiation recall syndrome
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
19.3%
11/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
21.1%
12/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.8%
9/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood creatinine increased
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
64.9%
37/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
24.6%
14/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Metabolic/laboratory - Other
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
38.6%
22/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
29.8%
17/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
45.6%
26/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
59.6%
34/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
19.3%
11/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
59.6%
34/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.8%
9/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.1%
16/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.3%
11/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.0%
8/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.3%
15/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.1%
12/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
8/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
29.8%
17/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.3%
11/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
14.0%
8/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
15.8%
9/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
14.0%
8/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
49.1%
28/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusional state
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
21.1%
12/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
71.9%
41/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
80.7%
46/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis NOS
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
14.0%
8/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
24.6%
14/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
35.1%
20/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
17.5%
10/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged chest tube drainage or air leak after pulmonary resection
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
12.3%
7/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic NOS
|
5.3%
3/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.9%
25/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - Other
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.3%
7/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
8/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
31.6%
18/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
12.3%
7/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hot flushes NOS
|
7.0%
4/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension NOS
|
10.5%
6/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thrombosis
|
8.8%
5/57
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place