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Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-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: NCT00066222
Recruitment Status : Completed
First Posted : August 7, 2003
Results First Posted : December 18, 2014
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Cisplatin
Drug: Etoposide
Radiation: Radiation therapy
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Period Title: Overall Study
Started 72
Completed 71 [1]
Not Completed 1
Reason Not Completed
No protocol treatment received             1
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Baseline Participants 71
Hide Baseline Analysis Population Description
Eligible patients who started protocol treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 71 participants
71
(43 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants
Female
34
  47.9%
Male
37
  52.1%
1.Primary Outcome
Title Overall Survival at 2 Years
Hide Description Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame From registration to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment.
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.60
(25.60 to 47.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Chemotherapy
Comments This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.
2.Secondary Outcome
Title Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year
Hide Description An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
Time Frame From registration to one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Participants Analyzed 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Overall Survival
77.5
(65.9 to 85.5)
Progression-free Survival
42.3
(30.7 to 53.4)
3.Secondary Outcome
Title Median Overall Survival Time and Progression-free Survival Time
Hide Description An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
Time Frame From registration to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Participants Analyzed 71
Median (95% Confidence Interval)
Unit of Measure: months
Overall Survival
19.0
(16.7 to 21.7)
Progression-free Survival
9.9
(7.9 to 12.4)
4.Secondary Outcome
Title Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis
Hide Description Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity 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 toxicity.
Time Frame From start of radiation therapy until 90 days following the start of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
13
  18.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Chemotherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.
5.Secondary Outcome
Title Frequency of Treatment-related Fatalities at 2 Years
Hide Description A treatment-related fatality was any death judged to be related to protocol treatment.
Time Frame From the start of treatment to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Chemotherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.
6.Secondary Outcome
Title Tumor Response
Hide Description Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): >= 20% increase in the sum of the 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 (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame From the start of treatment to 2 months following the completion of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and were observed for at least 2 months post-treatment
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Number of Participants Analyzed 68
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
29
  42.6%
Partial Response
28
  41.2%
Stable Disease
7
  10.3%
Progressive Disease
4
   5.9%
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
 
Arm/Group Title Radiation Therapy + Chemotherapy
Hide Arm/Group Description Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
All-Cause Mortality
Radiation Therapy + Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiation Therapy + Chemotherapy
Affected / at Risk (%)
Total   67/71 (94.37%) 
Blood and lymphatic system disorders   
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  14/71 (19.72%) 
Hematologic-Other * 1  1/71 (1.41%) 
Hemoglobin (Hgb) * 1  18/71 (25.35%) 
Hemoglobin (Hgb) for leukemia * 1  1/71 (1.41%) 
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other) * 1  1/71 (1.41%) 
Thrombotic microangiopathy for BMT (e.g., thrombotic thrombocytopenic purpura/TTP or hemolytic urem * 1  1/71 (1.41%) 
Transfusion: Platelets * 1  2/71 (2.82%) 
Transfusion: pRBCs * 1  2/71 (2.82%) 
Cardiac disorders   
Arrhythmia- other * 1  1/71 (1.41%) 
Circulatory or cardiac-Other * 1  1/71 (1.41%) 
Late RT Toxicity: Heart: NOS  2  1/71 (1.41%) 
Pericardial effusion/pericarditis * 1  1/71 (1.41%) 
Sinus tachycardia * 1  1/71 (1.41%) 
Gastrointestinal disorders   
Colitis * 1  1/71 (1.41%) 
Diarrhea (without colostomy) * 1  2/71 (2.82%) 
Dysphagia, esophagitis, odynophagia (painful swallowing) * 1  7/71 (9.86%) 
Dysphagia-esophageal related to radiation * 1  6/71 (8.45%) 
GI-Other * 1  1/71 (1.41%) 
Mucositis due to radiation * 1  1/71 (1.41%) 
Nausea * 1  14/71 (19.72%) 
Stomatitis/pharyngitis (oral/pharyngeal mucositis) * 1  1/71 (1.41%) 
Vomiting * 1  12/71 (16.90%) 
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  1/71 (1.41%) 
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) * 1  1/71 (1.41%) 
Pain-Other * 1  4/71 (5.63%) 
Hepatobiliary disorders   
Hepatic-Other * 1  1/71 (1.41%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever) * 1  1/71 (1.41%) 
Infections and infestations   
Infection with grade 3 or 4 neutropenia * 1  7/71 (9.86%) 
Infection with unknown ANC * 1  1/71 (1.41%) 
Infection without neutropenia * 1  3/71 (4.23%) 
Infection, Other * 1  1/71 (1.41%) 
Wound-infectious * 1  1/71 (1.41%) 
Injury, poisoning and procedural complications   
Operative injury of vein/artery * 1  1/71 (1.41%) 
Investigations   
Bilirubin * 1  1/71 (1.41%) 
Cardiac troponin T (cTnT) * 1  1/71 (1.41%) 
Creatinine * 1  3/71 (4.23%) 
Leukocytes (total WBC) * 1  53/71 (74.65%) 
Lymphopenia * 1  7/71 (9.86%) 
Neutrophils/granulocytes (ANC/AGC) * 1  56/71 (78.87%) 
Platelets * 1  4/71 (5.63%) 
SIADH (syndrome of inappropriate anti-diuretic hormone) * 1  1/71 (1.41%) 
Weight loss * 1  1/71 (1.41%) 
Metabolism and nutrition disorders   
Anorexia * 1  4/71 (5.63%) 
Dehydration * 1  8/71 (11.27%) 
Hyperglycemia * 1  3/71 (4.23%) 
Hyperkalemia * 1  1/71 (1.41%) 
Hypernatremia * 1  3/71 (4.23%) 
Hypocalcemia * 1  2/71 (2.82%) 
Hypokalemia * 1  8/71 (11.27%) 
Hypomagnesmia * 1  2/71 (2.82%) 
Hyponatremia * 1  9/71 (12.68%) 
Nervous system disorders   
CNS cerebrovascular ischemia * 1  1/71 (1.41%) 
Depressed level of consciousness * 1  1/71 (1.41%) 
Memory loss * 1  1/71 (1.41%) 
Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or * 1  3/71 (4.23%) 
Neuropathy motor * 1  1/71 (1.41%) 
Neuropathy-sensory * 1  2/71 (2.82%) 
Seizure(s) * 1  1/71 (1.41%) 
Syncope * 1  1/71 (1.41%) 
Renal and urinary disorders   
Incontinence * 1  1/71 (1.41%) 
Renal failure * 1  4/71 (5.63%) 
Respiratory, thoracic and mediastinal disorders   
Apnea * 1  1/71 (1.41%) 
Cough * 1  2/71 (2.82%) 
Dyspnea (shortness of breath) * 1  5/71 (7.04%) 
Late RT Toxicity: Lung: NOS  2  1/71 (1.41%) 
Pleuritic pain * 1  1/71 (1.41%) 
Pneumonitis/pulmonary infiltrates * 1  1/71 (1.41%) 
Pulmonary-Other * 1  3/71 (4.23%) 
Vascular disorders   
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia * 1  1/71 (1.41%) 
Hypotension * 1  3/71 (4.23%) 
Peripheral arterial ischemia * 1  1/71 (1.41%) 
Thrombosis/embolism * 1  4/71 (5.63%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiation Therapy + Chemotherapy
Affected / at Risk (%)
Total   71/71 (100.00%) 
Blood and lymphatic system disorders   
Hematologic-Other * 1  5/71 (7.04%) 
Hemoglobin (Hgb) * 1  48/71 (67.61%) 
Cardiac disorders   
Edema * 1  5/71 (7.04%) 
Gastrointestinal disorders   
Constipation * 1  17/71 (23.94%) 
Diarrhea (without colostomy) * 1  11/71 (15.49%) 
Dyspepsia/heartburn * 1  6/71 (8.45%) 
Dysphagia, esophagitis, odynophagia (painful swallowing) * 1  25/71 (35.21%) 
Dysphagia-esophageal related to radiation * 1  24/71 (33.80%) 
Dysphagia-pharyngeal related to radiation * 1  4/71 (5.63%) 
GI-Other * 1  6/71 (8.45%) 
Late RT Toxicity: Esophagus: NOS  2  13/71 (18.31%) 
Nausea * 1  38/71 (53.52%) 
Stomatitis/pharyngitis (oral/pharyngeal mucositis) * 1  6/71 (8.45%) 
Vomiting * 1  24/71 (33.80%) 
General disorders   
Chest pain (non-cardiac and non-pleuritic) * 1  5/71 (7.04%) 
Fatigue (lethargy, malaise, asthenia) * 1  55/71 (77.46%) 
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L) * 1  6/71 (8.45%) 
Late RT Toxicity: Other: NOS  2  17/71 (23.94%) 
Pain due to radiation * 1  9/71 (12.68%) 
Pain-Other * 1  11/71 (15.49%) 
Injury, poisoning and procedural complications   
Late RT Toxicity: Skin: NOS  2  7/71 (9.86%) 
Radiation dermatitis * 1  18/71 (25.35%) 
Investigations   
Alkaline phosphatase * 1  4/71 (5.63%) 
Creatinine * 1  14/71 (19.72%) 
Leukocytes (total WBC) * 1  10/71 (14.08%) 
Lymphopenia * 1  7/71 (9.86%) 
Neutrophils/granulocytes (ANC/AGC) * 1  6/71 (8.45%) 
Platelets * 1  48/71 (67.61%) 
Weight loss * 1  20/71 (28.17%) 
Metabolism and nutrition disorders   
Anorexia * 1  33/71 (46.48%) 
Dehydration * 1  19/71 (26.76%) 
Hyperglycemia * 1  12/71 (16.90%) 
Hyperkalemia * 1  6/71 (8.45%) 
Hypoalbuminemia * 1  12/71 (16.90%) 
Hypocalcemia * 1  12/71 (16.90%) 
Hypokalemia * 1  5/71 (7.04%) 
Hypomagnesmia * 1  17/71 (23.94%) 
Hyponatremia * 1  13/71 (18.31%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness (not due to neuropathy) * 1  6/71 (8.45%) 
Myalgia (muscle ache) * 1  4/71 (5.63%) 
Nervous system disorders   
Ataxia (incoordination) * 1  5/71 (7.04%) 
Dizziness/lightheadedness * 1  14/71 (19.72%) 
Headache * 1  8/71 (11.27%) 
Memory loss * 1  5/71 (7.04%) 
Neuropathy motor * 1  4/71 (5.63%) 
Neuropathy-sensory * 1  7/71 (9.86%) 
Taste disturbance (dysgeusia) * 1  4/71 (5.63%) 
Psychiatric disorders   
Insomnia * 1  6/71 (8.45%) 
Mood alteration-depression * 1  5/71 (7.04%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  24/71 (33.80%) 
Dyspnea (shortness of breath) * 1  17/71 (23.94%) 
Late RT Toxicity: Lung: NOS  2  37/71 (52.11%) 
Pneumonitis/pulmonary infiltrates * 1  4/71 (5.63%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  30/71 (42.25%) 
Vascular disorders   
Hypotension * 1  5/71 (7.04%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
Publications of Results:
Komaki R, Paulus R, Ettinger DS, et al.: A phase II study of accelerated high-dose thoracic radiation therapy (AHTRT) with concurrent chemotherapy for limited small cell lung cancer: RTOG 0239. [Abstract] J Clin Oncol 27 (Suppl 15): A-7527, 2009.
Komaki R, Moughan J, Ettinger D, et al.: Toxicities in a phase II study of accelerated high dose thoracic radiation therapy (TRT) with concurrent chemotherapy for limited small cell lung cancer (LSCLC) (RTOG 0239). [Abstract] J Clin Oncol 25 (Suppl 18): A-7717, 438s, 2007.
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00066222     History of Changes
Other Study ID Numbers: RTOG-0239
CDR0000271939
First Submitted: August 6, 2003
First Posted: August 7, 2003
Results First Submitted: December 10, 2014
Results First Posted: December 18, 2014
Last Update Posted: December 22, 2017