Comparison · NCT00680901-32cd7ba4
CapeOx Plus Lapatinib vs CapeOx Plus Placebo: Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CapeOx Plus Lapatinib vs CapeOx Plus Placebo: Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR). Trial comparisons, record NCT00680901-32cd7ba4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00680901-32cd7ba4
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.526 | 0.464 | 0.587 | wilson | |
| Risk in group 2 | 0.395 | 0.335 | 0.458 | wilson | |
| Risk difference, group 1 minus group 2 | 0.131 | 0.0426 | 0.217 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 1.09 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 1.7 | 1.19 | 2.44 | log | |
| Number needed to treat, for one more participant with the outcome on CapeOx Plus Lapatinib than on CapeOx Plus Placebo | 7.63 | 4.61 | 23.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CapeOx Plus Lapatinib | Participants received a combination therapy consisting of:~1. Oxaliplatin (Ox): 130 mg/m² intravenously on Day 1 of each 21-day cycle, for up to 8 cycles.~2. Capecitabine (Cape): 1700 mg/m² per day, taken orally in two divided doses from the evening of Day 1 to the morning of Day 15 (28 doses per cycle), followed by a minimum 6.5-day rest period. The dose could be increased to 2000 mg/m²/day after the first cycle at the investigator's discretion.~3. Lapatinib: 1250 mg orally once daily, starting on Day 1 and continued daily throughout the cycle, including the rest period.~After discontinuing oxaliplatin, capecitabine and lapatinib were continued until disease progression, unacceptable toxicity, or withdrawal of consent. | 131 | 249 | OG000 |
| Group 2 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:~1. Oxaliplatin (Ox): 130 mg/m² intravenously on Day 1 of each 21-day cycle, for up to 8 cycles.~2. Capecitabine (Cape): 1700 mg/m² per day, taken orally in two divided doses from the evening of Day 1 to the morning of Day 15 (28 doses per cycle), followed by a minimum 6.5-day rest period. The dose could be increased to 2000 mg/m²/day after the first cycle at the investigator's discretion.~3. Lapatinib matching placebo: Taken orally once daily starting on Day 1 and continued throughout each cycle, including the rest period.~After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. | 94 | 238 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR)
- Description
A participant was considered a responder if they had achieved either a complete response (CR), defined as the disappearance of all target and non-target lesions, or a partial response (PR), defined as at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, as assessed by the investigator and confirmed by radiographic imaging within four weeks of the initial observation.
- Time frame
- From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
- Population
- Primary Efficacy (PE) population
Source ClinicalTrials.gov
Trial
- Title
- LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
- NCT number
- NCT00680901
- Phases
- PHASE3
- Conditions
- Neoplasms, Gastrointestinal Tract
- Interventions
- Lapatinib, Placebo, Capecitabine, Oxaliplatin
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2013-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00680901?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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