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S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00045162
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : July 9, 2013
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: cisplatin
Drug: etoposide
Drug: irinotecan hydrochloride
Enrollment 671
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 336 335
Completed 194 217
Not Completed 142 118
Reason Not Completed
Ineligible             12             8
Not treated             7             2
Adverse Event             55             50
Lack of Efficacy             32             29
Death             10             10
Withdrawal by Subject             5             3
Not specified             21             16
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 324 327 651
Hide Baseline Analysis Population Description
Eleven ineligible patients on the cisplatin + irinotecan arm, and eight ineligible patients on the cisplatin + etoposide arm were excluded from the analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 324 participants 327 participants 651 participants
62
(22 to 85)
63
(35 to 88)
62
(22 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 324 participants 327 participants 651 participants
Female
136
  42.0%
145
  44.3%
281
  43.2%
Male
188
  58.0%
182
  55.7%
370
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 324 participants 327 participants 651 participants
Hispanic or Latino
7
   2.2%
7
   2.1%
14
   2.2%
Not Hispanic or Latino
289
  89.2%
288
  88.1%
577
  88.6%
Unknown or Not Reported
28
   8.6%
32
   9.8%
60
   9.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 324 participants 327 participants 651 participants
American Indian or Alaska Native 2 0 2
Asian 4 1 5
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 14 18 32
White 300 304 604
More than one race 2 0 2
Unknown or Not Reported 2 4 6
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Time Frame Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 324 327
Median (95% Confidence Interval)
Unit of Measure: Months
9.9
(9.2 to 11.1)
9.1
(8.4 to 9.9)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.
Time Frame Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 324 327
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(5.1 to 6.1)
5.2
(4.9 to 5.5)
3.Secondary Outcome
Title Confirmed and Unconfirmed Complete and Partial Responses.
Hide Description Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.
Time Frame Every 6 weeks while on protocol treatment for a maximum of 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 324 327
Measure Type: Number
Unit of Measure: participants
197 190
4.Secondary Outcome
Title Number of Patients With a Given Type and Grade of Adverse Event.
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.
Time Frame Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment.
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 321 327
Measure Type: Number
Unit of Measure: Participants
ARDS 0 1
Abdominal pain/cramping 8 8
Acidosis 2 1
Alkaline phosphatase increase 2 2
Allergic reaction 0 2
Anal incontinence 0 1
Anemia 19 40
Anorexia 36 17
Anxiety/agitation 0 1
Apnea 1 0
Arrhythmia, NOS 0 1
Arthralgia 0 1
Ataxia (incoordination) 1 2
Bilirubin increase 1 1
Blurred vision 0 1
Bone pain 8 6
Cardiac ischemia/infarction 1 2
Cardiovascular-other 1 1
Cataract 1 0
Cerebrovascular ischemia 1 7
Chest pain,not cardio or pleur 4 2
Colitis 2 1
Confusion 3 4
Constipation/bowel obstruction 4 4
Creatinine increase 9 7
Dehydration 54 27
Delusions 1 0
Depression 1 1
Diarrhea without colostomy 61 9
Dizziness/light headedness 2 4
Dyspepsia/heartburn 1 0
Dyspnea 27 21
Edema 1 1
Epistaxis 0 1
Erythema multiforme/blistering 0 1
Esophagitis/dysphagia 2 3
Fatigue/malaise/lethargy 45 35
Febrile neutropenia 11 33
Fever without neutropenia 1 0
Flu-like symptoms-other 2 2
GGT increase 0 1
GI Mucositis, NOS 0 2
GI-other 1 1
GU-other 2 0
Gastric ulcer 0 1
Gastritis 0 1
Headache 2 1
Hematemesis 0 1
Hematologic-other 1 0
Hemorrhage-other 0 1
Hyperglycemia 12 17
Hyperkalemia 3 1
Hypermagnesemia 1 0
Hypernatremia 1 2
Hypertension 2 4
Hyperuricemia 1 2
Hypoalbuminemia 2 7
Hypocalcemia 6 8
Hypoglycemia 2 3
Hypokalemia 19 21
Hypomagnesemia 3 7
Hyponatremia 38 28
Hypophosphatemia 7 5
Hypotension 14 8
Hypoxia 7 6
Ileus 2 0
Infection w/o 3-4 neutropenia 12 13
Infection with 3-4 neutropenia 20 24
Infection, unk ANC 2 3
Inner ear-hearing loss 1 4
Insomnia 1 2
Joint,muscle,bone-other 0 1
LVEF decrease/CHF 1 0
Leukopenia 57 109
Lipase increase 1 0
Lung-other 0 2
Lymphopenia 8 9
Melena/ GI bleeding 1 0
Metabolic-other 1 0
Mood/consciousness change, NOS 0 1
Muscle weakness (not neuro) 4 3
Myalgia 1 3
Nausea 46 35
Neuro-other 0 1
Neutropenia/granulocytopenia 108 224
PRBC transfusion 36 62
Pain-other 3 7
Personality/behavioral change 1 0
Platelet transfusion 1 13
Pneumonitis/infiltrates 4 2
Pneumothorax 0 1
Prothrombin time increase 3 2
Pruritus 0 1
RT-pain 0 1
Rash/desquamation 0 3
Renal failure 4 7
Reportable adverse event, NOS 1 1
Respiratory infect w/ neutrop 3 1
Respiratory infect w/o neutrop 3 1
Respiratory infection, unk ANC 1 0
SGOT (AST) increase 3 4
SGPT (ALT) increase 3 3
SIADH 2 3
Second primary 2 0
Seizures 2 1
Sensory neuropathy 1 1
Sinus tachycardia 0 1
Somnolence/consciousness loss 2 1
Stomatitis/pharyngitis 1 0
Supraventricular arrhythmia 3 0
Syncope 5 7
Thrombocytopenia 13 52
Thrombosis/embolism 8 15
Thrombotic microangiopathy 1 0
Tumor lysis syndrome 2 2
Ureteral obstruction 0 1
Urinary electrolyte wasting 0 1
Urinary retention 1 1
Urinary tr infect w/ neutrop 1 0
Ventricular arrhythmia 1 1
Voice change/stridor/larynx 2 0
Vomiting 34 30
Weakness (motor neuropathy) 1 0
Weight loss 3 1
Time Frame Patients were evaluated for adverse events prior to the beginning of each cycle of treatment, approximately every 4 weeks, for up to a maximum of 4 cycles (16 weeks).
Adverse Event Reporting Description Eligible patients who received at least one dose of treatment were included in the analysis of adverse events.
 
Arm/Group Title Cisplatin + Irinotecan Cisplatin + Etoposide
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Cisplatin + Irinotecan Cisplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cisplatin + Irinotecan Cisplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%)
Total   107/321 (33.33%)   31/327 (9.48%) 
Blood and lymphatic system disorders     
Anemia  1  3/321 (0.93%)  0/327 (0.00%) 
Febrile neutropenia  1  5/321 (1.56%)  0/327 (0.00%) 
PRBC transfusion  1  1/321 (0.31%)  0/327 (0.00%) 
Platelet transfusion  1  2/321 (0.62%)  0/327 (0.00%) 
Thrombotic microangiopathy  1  1/321 (0.31%)  0/327 (0.00%) 
Cardiac disorders     
Cardiac ischemia/infarction  1  0/321 (0.00%)  1/327 (0.31%) 
Cardiovascular-other  1  2/321 (0.62%)  0/327 (0.00%) 
LVEF decrease/CHF  1  1/321 (0.31%)  0/327 (0.00%) 
Supraventricular arrhythmia  1  4/321 (1.25%)  0/327 (0.00%) 
Ventricular arrhythmia  1  3/321 (0.93%)  1/327 (0.31%) 
Gastrointestinal disorders     
Abdominal pain/cramping  1  2/321 (0.62%)  0/327 (0.00%) 
Colitis  1  1/321 (0.31%)  0/327 (0.00%) 
Constipation/bowel obstruction  1  1/321 (0.31%)  0/327 (0.00%) 
Diarrhea without colostomy  1  29/321 (9.03%)  0/327 (0.00%) 
Gastritis  1  1/321 (0.31%)  0/327 (0.00%) 
Nausea  1  8/321 (2.49%)  0/327 (0.00%) 
Rectal bleeding/hematochezia  1  0/321 (0.00%)  1/327 (0.31%) 
Stomatitis/pharyngitis  1  1/321 (0.31%)  0/327 (0.00%) 
Vomiting  1  13/321 (4.05%)  0/327 (0.00%) 
General disorders     
Edema  1  2/321 (0.62%)  0/327 (0.00%) 
Fatigue/malaise/lethargy  1  11/321 (3.43%)  0/327 (0.00%) 
Flu-like symptoms-other  1  11/321 (3.43%)  6/327 (1.83%) 
Pain-other  1  2/321 (0.62%)  0/327 (0.00%) 
Reportable adverse event, NOS  1  1/321 (0.31%)  4/327 (1.22%) 
Infections and infestations     
Infection w/o 3-4 neutropenia  1  6/321 (1.87%)  1/327 (0.31%) 
Infection with 3-4 neutropenia  1  8/321 (2.49%)  6/327 (1.83%) 
Infection, unk ANC  1  1/321 (0.31%)  0/327 (0.00%) 
Respiratory infect w/ neutrop  1  2/321 (0.62%)  1/327 (0.31%) 
Respiratory infect w/o neutrop  1  2/321 (0.62%)  0/327 (0.00%) 
Respiratory infection, unk ANC  1  2/321 (0.62%)  0/327 (0.00%) 
Urinary tr infect w/ neutrop  1  1/321 (0.31%)  0/327 (0.00%) 
Investigations     
Abnormal troponin I (cTnI)  1  1/321 (0.31%)  1/327 (0.31%) 
Amylase increase  1  1/321 (0.31%)  0/327 (0.00%) 
CPK increase  1  1/321 (0.31%)  0/327 (0.00%) 
Creatinine increase  1  9/321 (2.80%)  1/327 (0.31%) 
Leukopenia  1  5/321 (1.56%)  0/327 (0.00%) 
Lipase increase  1  1/321 (0.31%)  0/327 (0.00%) 
Neutropenia/granulocytopenia  1  19/321 (5.92%)  0/327 (0.00%) 
Prothrombin time increase  1  2/321 (0.62%)  0/327 (0.00%) 
SIADH  1  1/321 (0.31%)  0/327 (0.00%) 
Thrombocytopenia  1  1/321 (0.31%)  1/327 (0.31%) 
Weight loss  1  1/321 (0.31%)  0/327 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  7/321 (2.18%)  0/327 (0.00%) 
Dehydration  1  33/321 (10.28%)  0/327 (0.00%) 
Hyperglycemia  1  2/321 (0.62%)  1/327 (0.31%) 
Hyperkalemia  1  1/321 (0.31%)  0/327 (0.00%) 
Hypernatremia  1  1/321 (0.31%)  0/327 (0.00%) 
Hyperuricemia  1  0/321 (0.00%)  1/327 (0.31%) 
Hypoalbuminemia  1  1/321 (0.31%)  0/327 (0.00%) 
Hypocalcemia  1  1/321 (0.31%)  0/327 (0.00%) 
Hypoglycemia  1  2/321 (0.62%)  0/327 (0.00%) 
Hypokalemia  1  5/321 (1.56%)  0/327 (0.00%) 
Hypomagnesemia  1  0/321 (0.00%)  1/327 (0.31%) 
Hyponatremia  1  11/321 (3.43%)  1/327 (0.31%) 
Hypophosphatemia  1  1/321 (0.31%)  0/327 (0.00%) 
Tumor lysis syndrome  1  1/321 (0.31%)  0/327 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  2/321 (0.62%)  0/327 (0.00%) 
Chest pain,not cardio or pleur  1  1/321 (0.31%)  0/327 (0.00%) 
Joint,muscle,bone-other  1  2/321 (0.62%)  1/327 (0.31%) 
Muscle weakness (not neuro)  1  2/321 (0.62%)  0/327 (0.00%) 
Myalgia/arthralgia, NOS  1  1/321 (0.31%)  0/327 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Second primary  1  1/321 (0.31%)  0/327 (0.00%) 
Nervous system disorders     
Ataxia (incoordination)  1  1/321 (0.31%)  0/327 (0.00%) 
CNS hemorrhage  1  1/321 (0.31%)  0/327 (0.00%) 
Cerebrovascular ischemia  1  3/321 (0.93%)  1/327 (0.31%) 
Dizziness/vertigo, NOS  1  0/321 (0.00%)  1/327 (0.31%) 
Headache  1  1/321 (0.31%)  0/327 (0.00%) 
Neuropathic pain  1  1/321 (0.31%)  0/327 (0.00%) 
Seizures  1  1/321 (0.31%)  0/327 (0.00%) 
Syncope  1  2/321 (0.62%)  0/327 (0.00%) 
Weakness (motor neuropathy)  1  0/321 (0.00%)  1/327 (0.31%) 
Psychiatric disorders     
Anxiety/agitation  1  1/321 (0.31%)  0/327 (0.00%) 
Confusion  1  1/321 (0.31%)  0/327 (0.00%) 
Depression  1  1/321 (0.31%)  0/327 (0.00%) 
Hallucinations  1  1/321 (0.31%)  0/327 (0.00%) 
Mood/consciousness change, NOS  1  2/321 (0.62%)  0/327 (0.00%) 
Personality/behavioral change  1  1/321 (0.31%)  0/327 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/321 (0.31%)  1/327 (0.31%) 
Urinary electrolyte wasting  1  0/321 (0.00%)  1/327 (0.31%) 
Reproductive system and breast disorders     
Pelvic pain  1  1/321 (0.31%)  0/327 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ARDS  1  0/321 (0.00%)  1/327 (0.31%) 
Dyspnea  1  8/321 (2.49%)  3/327 (0.92%) 
Hemoptysis  1  1/321 (0.31%)  0/327 (0.00%) 
Hypoxia  1  5/321 (1.56%)  0/327 (0.00%) 
Pneumonitis/infiltrates  1  3/321 (0.93%)  0/327 (0.00%) 
Pneumothorax  1  0/321 (0.00%)  1/327 (0.31%) 
Vascular disorders     
Hypotension  1  9/321 (2.80%)  0/327 (0.00%) 
Peripheral arterial ischemia  1  1/321 (0.31%)  0/327 (0.00%) 
Thrombosis/embolism  1  10/321 (3.12%)  2/327 (0.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cisplatin + Irinotecan Cisplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%)
Total   314/321 (97.82%)   317/327 (96.94%) 
Blood and lymphatic system disorders     
Anemia  1  214/321 (66.67%)  240/327 (73.39%) 
Febrile neutropenia  1  0/321 (0.00%)  34/327 (10.40%) 
PRBC transfusion  1  35/321 (10.90%)  62/327 (18.96%) 
Ear and labyrinth disorders     
Ear-other  1  0/321 (0.00%)  18/327 (5.50%) 
Inner ear-hearing loss  1  0/321 (0.00%)  30/327 (9.17%) 
Gastrointestinal disorders     
Abdominal pain/cramping  1  64/321 (19.94%)  45/327 (13.76%) 
Constipation/bowel obstruction  1  73/321 (22.74%)  99/327 (30.28%) 
Diarrhea without colostomy  1  182/321 (56.70%)  85/327 (25.99%) 
Dyspepsia/heartburn  1  18/321 (5.61%)  26/327 (7.95%) 
Nausea  1  215/321 (66.98%)  228/327 (69.72%) 
Stomatitis/pharyngitis  1  31/321 (9.66%)  38/327 (11.62%) 
Vomiting  1  132/321 (41.12%)  142/327 (43.43%) 
General disorders     
Edema  1  51/321 (15.89%)  53/327 (16.21%) 
Fatigue/malaise/lethargy  1  233/321 (72.59%)  246/327 (75.23%) 
Pain-other  1  32/321 (9.97%)  46/327 (14.07%) 
Infections and infestations     
Infection w/o 3-4 neutropenia  1  43/321 (13.40%)  43/327 (13.15%) 
Infection with 3-4 neutropenia  1  0/321 (0.00%)  18/327 (5.50%) 
Investigations     
Alkaline phosphatase increase  1  50/321 (15.58%)  59/327 (18.04%) 
Creatinine increase  1  45/321 (14.02%)  66/327 (20.18%) 
Leukopenia  1  162/321 (50.47%)  208/327 (63.61%) 
Lymphopenia  1  0/321 (0.00%)  23/327 (7.03%) 
Neutropenia/granulocytopenia  1  175/321 (54.52%)  255/327 (77.98%) 
SGOT (AST) increase  1  41/321 (12.77%)  35/327 (10.70%) 
SGPT (ALT) increase  1  40/321 (12.46%)  37/327 (11.31%) 
Thrombocytopenia  1  79/321 (24.61%)  167/327 (51.07%) 
Weight loss  1  98/321 (30.53%)  85/327 (25.99%) 
Metabolism and nutrition disorders     
Anorexia  1  133/321 (41.43%)  133/327 (40.67%) 
Dehydration  1  76/321 (23.68%)  71/327 (21.71%) 
Hyperglycemia  1  87/321 (27.10%)  78/327 (23.85%) 
Hyperkalemia  1  17/321 (5.30%)  0/327 (0.00%) 
Hypoalbuminemia  1  51/321 (15.89%)  60/327 (18.35%) 
Hypocalcemia  1  55/321 (17.13%)  60/327 (18.35%) 
Hypoglycemia  1  0/321 (0.00%)  17/327 (5.20%) 
Hypokalemia  1  49/321 (15.26%)  50/327 (15.29%) 
Hypomagnesemia  1  43/321 (13.40%)  47/327 (14.37%) 
Hyponatremia  1  68/321 (21.18%)  72/327 (22.02%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  23/321 (7.17%)  33/327 (10.09%) 
Chest pain,not cardio or pleur  1  17/321 (5.30%)  0/327 (0.00%) 
Muscle weakness (not neuro)  1  18/321 (5.61%)  0/327 (0.00%) 
Myalgia  1  24/321 (7.48%)  20/327 (6.12%) 
Nervous system disorders     
Dizziness/light headedness  1  26/321 (8.10%)  29/327 (8.87%) 
Headache  1  25/321 (7.79%)  28/327 (8.56%) 
Sensory neuropathy  1  45/321 (14.02%)  52/327 (15.90%) 
Taste disturbance  1  23/321 (7.17%)  25/327 (7.65%) 
Psychiatric disorders     
Anxiety/agitation  1  17/321 (5.30%)  0/327 (0.00%) 
Depression  1  17/321 (5.30%)  0/327 (0.00%) 
Insomnia  1  28/321 (8.72%)  29/327 (8.87%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  48/321 (14.95%)  43/327 (13.15%) 
Dyspnea  1  106/321 (33.02%)  98/327 (29.97%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  132/321 (41.12%)  204/327 (62.39%) 
Rash/desquamation  1  0/321 (0.00%)  30/327 (9.17%) 
Vascular disorders     
Hypotension  1  21/321 (6.54%)  29/327 (8.87%) 
Thrombosis/embolism  1  0/321 (0.00%)  17/327 (5.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Publications of Results:
Natale RB, Lara PN, Chansky K, et al.: S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). [Abstract] J Clin Oncol 26 (Suppl 15): A-7512, 2008.
Hanna NH, Einhorn L, Sandler A, et al.: Randomized, phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated, extensive-stage (ES) small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 23 (Suppl 16): A-LBA7004, 622s, 2005.
Other Publications:
Lara P, Chansky K, Shibata T, et al.: Cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer (E-SCLC): Final "common arm": comparative outcomes analysis of JCOG 9511 and SWOG 0124. [Abstract] J Clin Oncol 27 (Suppl 15): A-8027, 2009.
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00045162     History of Changes
Other Study ID Numbers: CDR0000256908
S0124 ( Other Identifier: SWOG )
S0124 ( Other Identifier: NCCTG )
S0124 ( Other Identifier: CALGB )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2002
First Posted: January 27, 2003
Results First Submitted: April 16, 2013
Results First Posted: July 9, 2013
Last Update Posted: July 31, 2018