Trial · NCT00545948
Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer
NCT00545948, Phase 2, Terminated, Duke University; results first posted 2014-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer. Trials, record NCT00545948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00545948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer
- NCT number
- NCT00545948
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Vinorelbine followed by Cisplatin, Pemetrexed followed by Cisplatin
- First posted
- 2007-10-18
- Last updated
- 2014-07-21
- Results first posted
- 2014-06-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC | 2 years | Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive. |
| Secondary | Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy | 4 years | The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies. |
| Secondary | 2-Year Overall Survival in Patients Treated for NSCLC | 2 years | Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive |
| Secondary | Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer | Baseline | Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire. |
| Secondary | Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms | 2 years | Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented. |
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 | 2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC | 2 years | Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together. | percentage of treated patients | NUMBER |
| SECONDARY | Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy | 4 years | Percentage of participants | NUMBER | |
| SECONDARY | 2-Year Overall Survival in Patients Treated for NSCLC | 2 years | Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together. | percentage of treated patients | NUMBER |
| SECONDARY | Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer | Baseline | Twenty-six questionnaires were returned. There was insufficient numbers to provide for substantive analysis. | ||
| SECONDARY | Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms | 2 years | There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented. |
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 |
|---|---|---|---|---|---|
| 2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC | Treatment | 63.64 | 95% Confidence Interval 40.29 to 79.88 | percentage of treated patients | |
| Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy | All Registered Patients | 77.4 | Percentage of participants | ||
| 2-Year Overall Survival in Patients Treated for NSCLC | Treatment | 81.81 | 95% Confidence Interval 58.53 to 92.76 | percentage of treated patients |
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-Vinorelbine | 9 | |
| Overall Study | STARTED | Arm B-Pemetrexed | 15 | |
| Overall Study | STARTED | Screen Failures | 7 | |
| Overall Study | Assigned Treatment | Arm A-Vinorelbine | 9 | |
| Overall Study | Assigned Treatment | Arm B-Pemetrexed | 15 | |
| Overall Study | Assigned Treatment | Screen Failures | 0 | |
| Overall Study | COMPLETED | Arm A-Vinorelbine | 8 | |
| Overall Study | COMPLETED | Arm B-Pemetrexed | 14 | |
| Overall Study | COMPLETED | Screen Failures | 0 | |
| Overall Study | NOT COMPLETED | Arm A-Vinorelbine | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events234
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 A-Vinorelbine | 7 | 8 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B-Pemetrexed | 10 | 14 | |
| other | Atrial flutter | Cardiac disorders | Arm A-Vinorelbine | 1 | 8 | |
| other | Atrial flutter | Cardiac disorders | Arm B-Pemetrexed | 0 | 14 | |
| other | Cardiac disorders - Other, specify: Tachycardia | Cardiac disorders | Arm A-Vinorelbine | 2 | 8 | |
| other | Cardiac disorders - Other, specify: Tachycardia | Cardiac disorders | Arm B-Pemetrexed | 0 | 14 | |
| other | Ear and labyrinth disorders - Other, specify: vibrations and muffling | Ear and labyrinth disorders | Arm A-Vinorelbine | 0 | 8 | |
| other | Ear and labyrinth disorders - Other, specify: vibrations and muffling | Ear and labyrinth disorders | Arm B-Pemetrexed | 2 | 14 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm A-Vinorelbine | 0 | 8 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm B-Pemetrexed | 1 | 14 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A-Vinorelbine | ||
| Total, all-cause mortality | Arm B-Pemetrexed | ||
| Total, other adverse events | Arm A-Vinorelbine | 8 | 8 |
| Total, other adverse events | Arm B-Pemetrexed | 14 | 14 |
| Total, serious adverse events | Arm A-Vinorelbine | 4 | 8 |
| Total, serious adverse events | Arm B-Pemetrexed | 2 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A-Vinorelbine vs Arm B-Pemetrexed: 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/NCT00545948
GET https://conductscience.org/api/trials/v1/NCT00545948/events?page=2