Trial · NCT00045162

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

NCT00045162, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2013-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer. Trials, record NCT00045162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00045162

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
NCT number: NCT00045162
Status: Completed
Phases: Phase 3
Enrollment: 671 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Lung Cancer
Interventions: cisplatin, etoposide, irinotecan hydrochloride
First posted: 2003-01-27
Last updated: 2018-07-31
Results first posted: 2013-07-09

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.	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.
Secondary	Progression-free Survival	Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.	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.
Secondary	Confirmed and Unconfirmed Complete and Partial Responses.	Every 6 weeks while on protocol treatment for a maximum of 12 weeks	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.
Secondary	Number of Patients With a Given Type and Grade of Adverse Event.	Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.		Months	MEDIAN
SECONDARY	Progression-free Survival	Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.		months	MEDIAN
SECONDARY	Confirmed and Unconfirmed Complete and Partial Responses.	Every 6 weeks while on protocol treatment for a maximum of 12 weeks		participants	NUMBER
SECONDARY	Number of Patients With a Given Type and Grade of Adverse Event.	Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.	Eligible patients who received protocol treatment.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group254

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Cisplatin + Irinotecan		9.9	95% Confidence Interval 9.2 to 11.1	Months
Overall Survival	Cisplatin + Etoposide		9.1	95% Confidence Interval 8.4 to 9.9	Months
Progression-free Survival	Cisplatin + Irinotecan		5.7	95% Confidence Interval 5.1 to 6.1	months
Progression-free Survival	Cisplatin + Etoposide		5.2	95% Confidence Interval 4.9 to 5.5	months
Confirmed and Unconfirmed Complete and Partial Responses.	Cisplatin + Irinotecan		197		participants
Confirmed and Unconfirmed Complete and Partial Responses.	Cisplatin + Etoposide		190		participants
Number of Patients With a Given Type and Grade of Adverse Event.	Cisplatin + Irinotecan	ARDS	0		Participants
Number of Patients With a Given Type and Grade of Adverse Event.	Cisplatin + Etoposide	ARDS	1		Participants
Number of Patients With a Given Type and Grade of Adverse Event.	Cisplatin + Irinotecan	Abdominal pain/cramping	8		Participants
Number of Patients With a Given Type and Grade of Adverse Event.	Cisplatin + Etoposide	Abdominal pain/cramping	8		Participants

1 to 10 of 254Source ClinicalTrials.gov

See all 254 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cisplatin + Irinotecan	336
Overall Study	STARTED	Cisplatin + Etoposide	335
Overall Study	COMPLETED	Cisplatin + Irinotecan	194
Overall Study	COMPLETED	Cisplatin + Etoposide	217
Overall Study	NOT COMPLETED	Cisplatin + Irinotecan	142
Overall Study	NOT COMPLETED	Cisplatin + Etoposide	118

Source ClinicalTrials.gov

Adverse events284

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Cisplatin + Irinotecan	214	321
other	Anemia	Blood and lymphatic system disorders	Cisplatin + Etoposide	240	327
other	Febrile neutropenia	Blood and lymphatic system disorders	Cisplatin + Irinotecan	0	321
other	Febrile neutropenia	Blood and lymphatic system disorders	Cisplatin + Etoposide	34	327
other	PRBC transfusion	Blood and lymphatic system disorders	Cisplatin + Irinotecan	35	321
other	PRBC transfusion	Blood and lymphatic system disorders	Cisplatin + Etoposide	62	327
other	Ear-other	Ear and labyrinth disorders	Cisplatin + Irinotecan	0	321
other	Ear-other	Ear and labyrinth disorders	Cisplatin + Etoposide	18	327
other	Inner ear-hearing loss	Ear and labyrinth disorders	Cisplatin + Irinotecan	0	321
other	Inner ear-hearing loss	Ear and labyrinth disorders	Cisplatin + Etoposide	30	327

1 to 10 of 284Source ClinicalTrials.gov

See all 284 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cisplatin + Irinotecan
Total, all-cause mortality	Cisplatin + Etoposide
Total, other adverse events	Cisplatin + Irinotecan	314	321
Total, other adverse events	Cisplatin + Etoposide	317	327
Total, serious adverse events	Cisplatin + Irinotecan	107	321
Total, serious adverse events	Cisplatin + Etoposide	31	327

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16648503	RESULT	PubMed
19349543	RESULT	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cisplatin + Irinotecan vs Cisplatin + Etoposide: Confirmed and Unconfirmed Complete and Partial Responses.	Trial comparisons
Cisplatin + Irinotecan vs Cisplatin + Etoposide: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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