Trial · NCT00004859
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
NCT00004859, Phase 3, Terminated, National Cancer Institute (NCI); results first posted 2012-03-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer. Trials, record NCT00004859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
- NCT number
- NCT00004859
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 589 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lung Cancer
- Interventions
- carboplatin, paclitaxel, thalidomide, radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2014-06-02
- Results first posted
- 2012-03-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Time | every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5 | Survival time is defined as time from study entry to death from any cause |
| Secondary | Time to Disease Progression | every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year | Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. |
| Secondary | Response Rate at Best Response to Treatment | every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year | Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Time to Disease Progression | every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year | Months | MEDIAN | |
| SECONDARY | Response Rate at Best Response to Treatment | every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year | Proportion of participants | NUMBER | |
| PRIMARY | Overall Survival Time | every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5 | intent to treat analysis in the 546 eligible patients | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Disease Progression | Arm A (Paclitaxel + Carboplatin + Radiation ) | 7.4 | 95% Confidence Interval 6.6 to 8.6 | Months | |
| Time to Disease Progression | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 7.8 | 95% Confidence Interval 6.9 to 8.8 | Months | |
| Response Rate at Best Response to Treatment | Arm A (Paclitaxel + Carboplatin + Radiation ) | 0.35 | 95% Confidence Interval 0.29 to 0.41 | Proportion of participants | |
| Response Rate at Best Response to Treatment | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 0.38 | 95% Confidence Interval 0.32 to 0.44 | Proportion of participants | |
| Overall Survival Time | Arm A (Paclitaxel + Carboplatin + Radiation ) | 15.3 | 95% Confidence Interval 12.4 to 20.6 | Months | |
| Overall Survival Time | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 16.0 | 95% Confidence Interval 14.5 to 18.5 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Paclitaxel + Carboplatin + Radiation ) | 295 | |
| Overall Study | STARTED | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 294 | |
| Overall Study | Eligible | Arm A (Paclitaxel + Carboplatin + Radiation ) | 275 | |
| Overall Study | Eligible | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 271 | |
| Overall Study | Treated | Arm A (Paclitaxel + Carboplatin + Radiation ) | 289 | |
| Overall Study | Treated | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 289 | |
| Overall Study | Treated and Having Toxicity Data | Arm A (Paclitaxel + Carboplatin + Radiation ) | 289 | |
| Overall Study | Treated and Having Toxicity Data | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 288 | |
| Overall Study | COMPLETED | Arm A (Paclitaxel + Carboplatin + Radiation ) | 177 | |
| Overall Study | COMPLETED | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events308
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 | Leukopenia | Investigations | Arm A (Paclitaxel + Carboplatin + Radiation ) | 223 | 289 | |
| other | Leukopenia | Investigations | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 229 | 288 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Paclitaxel + Carboplatin + Radiation ) | 238 | 289 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 238 | 288 | |
| other | Neutropenia | Investigations | Arm A (Paclitaxel + Carboplatin + Radiation ) | 187 | 289 | |
| other | Neutropenia | Investigations | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 220 | 288 | |
| other | Thrombocytopenia | Investigations | Arm A (Paclitaxel + Carboplatin + Radiation ) | 109 | 289 | |
| other | Thrombocytopenia | Investigations | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 108 | 288 | |
| other | Edema | General disorders | Arm A (Paclitaxel + Carboplatin + Radiation ) | 24 | 289 | |
| other | Edema | General disorders | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 83 | 288 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Paclitaxel + Carboplatin + Radiation ) | ||
| Total, all-cause mortality | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | ||
| Total, other adverse events | Arm A (Paclitaxel + Carboplatin + Radiation ) | 283 | 289 |
| Total, other adverse events | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 284 | 288 |
| Total, serious adverse events | Arm A (Paclitaxel + Carboplatin + Radiation ) | 222 | 289 |
| Total, serious adverse events | Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) | 249 | 288 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17406356 | RESULT |
Source 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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Paclitaxel + Carboplatin + Radiation ) vs Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide): serious adverse events |
Source 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.
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/NCT00004859
GET https://conductscience.org/api/trials/v1/NCT00004859/events?page=2