Trial · NCT00632853
Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
NCT00632853, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2023-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide. Trials, record NCT00632853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00632853
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
- NCT number
- NCT00632853
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 731 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Lung Cancer
- Interventions
- Standard Radiation Dose Therapy, cisplatin, etoposide, High Radiation Dose Therapy, carboplatin
- First posted
- 2008-03-11
- Last updated
- 2026-09-10
- Results first posted
- 2023-06-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Time | 11.25 years | Overall survival time is defined as the time between a patient's registration and death or end of survival follow up. |
| Secondary | Complete and Partial Response Rates | 11.25 years | |
| Secondary | Failure-free>> Survival | Up to 5 years | |
| Secondary | To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens. | 5 years | |
| Secondary | To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State. | 5 years | |
| Secondary | To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer. | 5 years | |
| Secondary | To Examine Blood-based Biomarkers of Response and Resistance to Cisplatin (or Carboplatin) and Etoposide. | 5 years | |
| Secondary | To Evaluate the Correspondence Between Increases in Plasma ProGRP Concentrations and Disease Progression/Recurrence | 5 years | |
| Secondary | To Evaluate the Potential for Plasma ProGRP Concentrations at Baseline, After Each Cycle of > Chemotherapy and at First Evaluation Following Completion of Chemotherapy to Predict PFS and OS. | 5 years | |
| Secondary | To Evaluate the Correspondence Between Longitudinal Decreases in Plasma ProGRP Concentrations and Clinical Response. | 5 years |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Time | 11.25 years | All registered patients were included in this analysis. | Months | MEDIAN |
| SECONDARY | Complete and Partial Response Rates | 11.25 years | |||
| SECONDARY | Failure-free >> Survival | Up to 5 years | |||
| SECONDARY | To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens. | 5 years | |||
| SECONDARY | To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State. | 5 years | |||
| SECONDARY | To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer. | 5 years | |||
| SECONDARY | To Examine Blood-based Biomarkers of Response and Resistance to Cisplatin (or Carboplatin) and Etoposide. | 5 years | |||
| SECONDARY | To Evaluate the Correspondence Between Increases in Plasma ProGRP Concentrations and Disease Progression/Recurrence | 5 years | |||
| SECONDARY | To Evaluate the Potential for Plasma ProGRP Concentrations at Baseline, After Each Cycle of > Chemotherapy and at First Evaluation Following Completion of Chemotherapy to Predict PFS and OS. | 5 years | |||
| SECONDARY | To Evaluate the Correspondence Between Longitudinal Decreases in Plasma ProGRP Concentrations and Clinical Response. | 5 years |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Time | Arm A | 28.7 | 95% Confidence Interval 26.2 to 35.5 | Months | |
| Overall Survival Time | Arm B | 30.5 | 95% Confidence Interval 24.4 to 39.6 | Months | |
| Overall Survival Time | Arm C | 32.3 | 95% Confidence Interval 21.1 to 44.8 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 313 | |
| Overall Study | STARTED | Arm B | 325 | |
| Overall Study | STARTED | Arm C | 93 | |
| Overall Study | COMPLETED | Arm A | 313 | |
| Overall Study | COMPLETED | Arm B | 325 | |
| Overall Study | COMPLETED | Arm C | 93 | |
| Overall Study | NOT COMPLETED | Arm A | 0 | |
| Overall Study | NOT COMPLETED | Arm B | 0 | |
| Overall Study | NOT COMPLETED | Arm C | 0 |
Source ClinicalTrials.gov
Adverse events789
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 | Events |
|---|---|---|---|---|---|---|
| other | Blood disorder | Blood and lymphatic system disorders | Arm A | 7 | 313 | 10 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm B | 7 | 325 | 12 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm C | 1 | 93 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A | 41 | 313 | 51 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B | 39 | 325 | 44 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm C | 11 | 93 | 13 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm A | 246 | 313 | 681 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm B | 247 | 325 | 660 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm C | 73 | 93 | 206 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm A | 2 | 313 | 2 |
1 to 10 of 789Source ClinicalTrials.gov
See all 789 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 206 | 313 |
| Total, all-cause mortality | Arm B | 220 | 325 |
| Total, all-cause mortality | Arm C | 73 | 93 |
| Total, other adverse events | Arm A | 292 | 313 |
| Total, other adverse events | Arm B | 296 | 325 |
| Total, other adverse events | Arm C | 87 | 93 |
| Total, serious adverse events | Arm A | 4 | 313 |
| Total, serious adverse events | Arm B | 11 | 325 |
| Total, serious adverse events | Arm C | 4 | 93 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00632853
GET https://conductscience.org/api/trials/v1/NCT00632853/events?page=2