Trial · NCT00548548
A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
NCT00548548, Phase 3, Completed, Genentech, Inc.; results first posted 2012-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer. Trials, record NCT00548548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00548548
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
- NCT number
- NCT00548548
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 774 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Adenocarcinoma
- Interventions
- Bevacizumab, Capecitabine, Cisplatin, Placebo, 5-fluorouracil
- First posted
- 2007-10-24
- Last updated
- 2017-06-14
- Results first posted
- 2012-01-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until death, up to 26 months | The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method. |
| Secondary | Progression-free Survival | From randomization until disease progression or death, up to 26 months. | Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Progression-free Survival During First-line Therapy | From randomization until 28-days after the last study treatment was administered, up to 26 months. | Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Time to Disease Progression | From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months. | Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method. |
| Secondary | Participants With a Best Overall Response of Complete or Partial Response | From randomization until the end of study, up to 26 months. | Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s). |
| Secondary | Duration of Response | From randomization to the end of study, up to 26 months | Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method. |
| Secondary | Participants With Disease Control | From randomization until the end of study, up to 26 months. | Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks. |
| Secondary | Participants With Adverse Events | From randomization until 3 months after last dose (up to 26 months) | The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until death, up to 26 months | The Intent-to-Treat population, including all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-free Survival | From randomization until disease progression or death, up to 26 months. | Intent to treat | months | MEDIAN |
| SECONDARY | Progression-free Survival During First-line Therapy | From randomization until 28-days after the last study treatment was administered, up to 26 months. | Intent-to treat. | months | MEDIAN |
| SECONDARY | Time to Disease Progression | From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months. | Intent-to-treat | months | MEDIAN |
| SECONDARY | Participants With a Best Overall Response of Complete or Partial Response | From randomization until the end of study, up to 26 months. | Measurable Disease Population, including all randomized participants with measurable disease (per RECIST) for gastric cancer at baseline. Patients were analyzed according to the treatment groups to which they were randomized. | participants | NUMBER |
| SECONDARY | Duration of Response | From randomization to the end of study, up to 26 months | Participants with measurable disease at baseline who had a best overall response of complete response or partial response, and for whom duration of response data was available. | months | MEDIAN |
| SECONDARY | Participants With Disease Control | From randomization until the end of study, up to 26 months. | Intent-to-treat | participants | NUMBER |
| SECONDARY | Participants With Adverse Events | From randomization until 3 months after last dose (up to 26 months) | Safety population, including all patients randomized and exposed to study medication (defined as any one component of the combination). Patients are assigned to treatment groups based on the treatment they actually received. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Bevacizumab | 12.1 | 95% Confidence Interval 11.1 to 13.8 | months | |
| Overall Survival | Placebo | 10.1 | 95% Confidence Interval 9.0 to 11.3 | months | |
| Progression-free Survival | Bevacizumab | 6.7 | 95% Confidence Interval 5.9 to 7.1 | months | |
| Progression-free Survival | Placebo | 5.3 | 95% Confidence Interval 4.4 to 5.6 | months | |
| Progression-free Survival During First-line Therapy | Bevacizumab | 6.9 | 95% Confidence Interval 6.2 to 7.3 | months | |
| Progression-free Survival During First-line Therapy | Placebo | 5.4 | 95% Confidence Interval 4.7 to 5.6 | months | |
| Time to Disease Progression | Bevacizumab | 7.0 | 95% Confidence Interval 6.5 to 7.6 | months | |
| Time to Disease Progression | Placebo | 5.6 | 95% Confidence Interval 5.1 to 5.8 | months | |
| Participants With a Best Overall Response of Complete or Partial Response | Bevacizumab | Responders | 143 | participants | |
| Participants With a Best Overall Response of Complete or Partial Response | Placebo | Responders | 111 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab | 387 | |
| Overall Study | STARTED | Placebo | 387 | |
| Overall Study | Treated | Bevacizumab | 383 | |
| Overall Study | Treated | Placebo | 384 | |
| Overall Study | Safety Population | Bevacizumab | 386 | |
| Overall Study | Safety Population | Placebo | 381 | |
| Overall Study | COMPLETED | Bevacizumab | 25 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 362 | |
| Overall Study | NOT COMPLETED | Placebo | 366 |
Source ClinicalTrials.gov
Adverse events458
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 | NAUSEA | Gastrointestinal disorders | Bevacizumab | 264 | 386 | |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 248 | 381 | |
| other | VOMITING | Gastrointestinal disorders | Bevacizumab | 192 | 386 | |
| other | VOMITING | Gastrointestinal disorders | Placebo | 188 | 381 | |
| other | DIARRHOEA | Gastrointestinal disorders | Bevacizumab | 180 | 386 | |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 142 | 381 | |
| other | CONSTIPATION | Gastrointestinal disorders | Bevacizumab | 141 | 386 | |
| other | CONSTIPATION | Gastrointestinal disorders | Placebo | 124 | 381 | |
| other | STOMATITIS | Gastrointestinal disorders | Bevacizumab | 111 | 386 | |
| other | STOMATITIS | Gastrointestinal disorders | Placebo | 88 | 381 |
1 to 10 of 458Source ClinicalTrials.gov
See all 458 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bevacizumab | 378 | 386 |
| Total, other adverse events | Placebo | 373 | 381 |
| Total, serious adverse events | Bevacizumab | 134 | 386 |
| Total, serious adverse events | Placebo | 137 | 381 |
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 |
|---|
| Bevacizumab vs Placebo: 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/NCT00548548
GET https://conductscience.org/api/trials/v1/NCT00548548/results?page=2