Trial · NCT00324805
Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery
NCT00324805, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2018-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery. Trials, record NCT00324805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00324805
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery
- NCT number
- NCT00324805
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,501 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage IIA Lung Non-Small Cell Carcinoma AJCC v7, Stage IIB Lung Non-Small Cell Carcinoma AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7
- Interventions
- Bevacizumab, Cisplatin, Docetaxel, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pemetrexed Disodium, Questionnaire Administration, Vinorelbine Tartrate
- First posted
- 2006-05-11
- Last updated
- 2026-06-23
- Results first posted
- 2018-02-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From registration to death, up to 10 years | Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint. |
| Secondary | Disease-free Survival | From registration to death, up to 10 years | Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment. |
| Other | Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 1 year post-treatment | If the difference in the rate of a particular category of toxicities between the 2 arms (N=750 per arm) is at least 5% (4% vs. 9%), 96% power can be attained assuming a significance level of 5% (two-sided Chi Square test) and that the lower toxicity rate for one arm is 4%. A difference in the rates of grade 3-5 arterial thromboembolic events and bleeding events will be monitored and assessed between the treatment arms. |
| Other | Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC. | From registration to death, up to 10 years | |
| Other | To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB - IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting. | From registration to death, up to 10 years |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From registration to death, up to 10 years | All enrolled patients | months | MEDIAN |
| SECONDARY | Disease-free Survival | From registration to death, up to 10 years | All enrolled patients | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 1 year post-treatment | |||
| OTHER_PRE_SPECIFIED | Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC. | From registration to death, up to 10 years | Data for these studies were not collected | ||
| OTHER_PRE_SPECIFIED | To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB - IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting. | From registration to death, up to 10 years | Data were not collected |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm I (Chemotherapy) | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival | Arm II (Chemotherapy, Bevacizumab) | 85.8 | 95% Confidence Interval 74.9 to NA | months | |
| Disease-free Survival | Arm I (Chemotherapy) | 42.9 | 95% Confidence Interval 36.7 to 57.0 | months | |
| Disease-free Survival | Arm II (Chemotherapy, Bevacizumab) | 40.6 | 95% Confidence Interval 35.5 to 49.5 | months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Chemotherapy) | 749 | |
| Overall Study | STARTED | Arm II (Chemotherapy, Bevacizumab) | 752 | |
| Overall Study | Started Assigned Therapy | Arm I (Chemotherapy) | 737 | |
| Overall Study | Started Assigned Therapy | Arm II (Chemotherapy, Bevacizumab) | 735 | |
| Overall Study | COMPLETED | Arm I (Chemotherapy) | 599 | |
| Overall Study | COMPLETED | Arm II (Chemotherapy, Bevacizumab) | 269 | |
| Overall Study | NOT COMPLETED | Arm I (Chemotherapy) | 150 | |
| Overall Study | NOT COMPLETED | Arm II (Chemotherapy, Bevacizumab) | 483 |
Source ClinicalTrials.gov
Adverse events332
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 | Anemia | Blood and lymphatic system disorders | Arm I (Chemotherapy) | 256 | 738 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Chemotherapy, Bevacizumab) | 183 | 735 | |
| other | Fatigue | General disorders | Arm I (Chemotherapy) | 62 | 738 | |
| other | Fatigue | General disorders | Arm II (Chemotherapy, Bevacizumab) | 68 | 735 | |
| other | Creatinine increased | Investigations | Arm I (Chemotherapy) | 169 | 738 | |
| other | Creatinine increased | Investigations | Arm II (Chemotherapy, Bevacizumab) | 247 | 735 | |
| other | Neutrophil count decreased | Investigations | Arm I (Chemotherapy) | 220 | 738 | |
| other | Neutrophil count decreased | Investigations | Arm II (Chemotherapy, Bevacizumab) | 236 | 735 | |
| other | Platelet count decreased | Investigations | Arm I (Chemotherapy) | 48 | 738 | |
| other | Platelet count decreased | Investigations | Arm II (Chemotherapy, Bevacizumab) | 49 | 735 |
1 to 10 of 332Source ClinicalTrials.gov
See all 332 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Chemotherapy) | ||
| Total, all-cause mortality | Arm II (Chemotherapy, Bevacizumab) | ||
| Total, other adverse events | Arm I (Chemotherapy) | 474 | 738 |
| Total, other adverse events | Arm II (Chemotherapy, Bevacizumab) | 509 | 735 |
| Total, serious adverse events | Arm I (Chemotherapy) | 424 | 738 |
| Total, serious adverse events | Arm II (Chemotherapy, Bevacizumab) | 563 | 735 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Chemotherapy) vs Arm II (Chemotherapy, Bevacizumab): 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/NCT00324805
GET https://conductscience.org/api/trials/v1/NCT00324805/events?page=2