Trial · NCT00911820
Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
NCT00911820, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2017-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer. Trials, record NCT00911820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00911820
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
- NCT number
- NCT00911820
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 88 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Esophageal Cancer, Gastric Cancer, Stomach Cancer
- Interventions
- Bevacizumab, Cisplatin, Irinotecan, Docetaxel
- First posted
- 2009-06-02
- Last updated
- 2022-11-08
- Results first posted
- 2017-11-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 7-month Progression-Free Survival | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up. | 7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
| Secondary | Overall Survival | Patients in the study cohort were followed up to approximately 2.5 years as of this analysis. | Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods. |
| Secondary | Best Response | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.. | Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria. |
| Secondary | Overall Response (OR) Rate | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis. | Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Progression-Free Survival | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis. | Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
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 | 7-month Progression-Free Survival | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up. | The analysis dataset is comprised of all treated patients. | probability | NUMBER |
| SECONDARY | Overall Survival | Patients in the study cohort were followed up to approximately 2.5 years as of this analysis. | The analysis dataset is comprised of all treated patients. | months | MEDIAN |
| SECONDARY | Best Response | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.. | The analysis dataset is comprised of all treated patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response (OR) Rate | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis. | The analysis dataset is comprised of all treated patients. | proportion of patients | NUMBER |
| SECONDARY | Progression-Free Survival | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis. | The analysis dataset is comprised of all treated patients. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 7-month Progression-Free Survival | Arm A: PCA | 0.581 | 95% Confidence Interval 0.421 to 0.712 | probability | |
| 7-month Progression-Free Survival | Arm B: TPCA | 0.582 | 95% Confidence Interval 0.410 to 0.719 | probability | |
| Overall Survival | Arm A: PCA | 11.7 | 95% Confidence Interval 9.6 to 15.4 | months | |
| Overall Survival | Arm B: TPCA | 13.4 | 95% Confidence Interval 11.5 to 16.1 | months | |
| Best Response | Arm A: PCA | Complete Response | 3 | Participants | |
| Best Response | Arm B: TPCA | Complete Response | 0 | Participants | |
| Best Response | Arm A: PCA | Partial Response | 22 | Participants | |
| Best Response | Arm B: TPCA | Partial Response | 21 | Participants | |
| Best Response | Arm A: PCA | Stable Disease | 15 | Participants | |
| Best Response | Arm B: TPCA | Stable Disease | 14 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: PCA | 45 | |
| Overall Study | STARTED | Arm B: TPCA | 43 | |
| Overall Study | Treated | Arm A: PCA | 44 | |
| Overall Study | Treated | Arm B: TPCA | 41 | |
| Overall Study | COMPLETED | Arm A: PCA | 0 | |
| Overall Study | COMPLETED | Arm B: TPCA | 0 | |
| Overall Study | NOT COMPLETED | Arm A: PCA | 45 | |
| Overall Study | NOT COMPLETED | Arm B: TPCA | 43 |
Source ClinicalTrials.gov
Adverse events534
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 | Abdomen, pain | Gastrointestinal disorders | Arm A: PCA | 17 | 44 | |
| other | Abdomen, pain | Gastrointestinal disorders | Arm B: TPCA | 19 | 41 | |
| other | Agitation | Psychiatric disorders | Arm A: PCA | 2 | 44 | |
| other | Agitation | Psychiatric disorders | Arm B: TPCA | 1 | 41 | |
| other | Alkaline phosphatase | Investigations | Arm A: PCA | 5 | 44 | |
| other | Alkaline phosphatase | Investigations | Arm B: TPCA | 5 | 41 | |
| other | Allergic reaction | Immune system disorders | Arm A: PCA | 1 | 44 | |
| other | Allergic reaction | Immune system disorders | Arm B: TPCA | 5 | 41 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm A: PCA | 3 | 44 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm B: TPCA | 7 | 41 |
1 to 10 of 534Source ClinicalTrials.gov
See all 534 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: PCA | 0 | 44 |
| Total, all-cause mortality | Arm B: TPCA | 3 | 41 |
| Total, other adverse events | Arm A: PCA | 44 | 44 |
| Total, other adverse events | Arm B: TPCA | 39 | 41 |
| Total, serious adverse events | Arm A: PCA | 32 | 44 |
| Total, serious adverse events | Arm B: TPCA | 36 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: PCA vs Arm B: TPCA: deaths from any cause | Trial comparisons |
| Arm A: PCA vs Arm B: TPCA: serious adverse events | 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/NCT00911820
GET https://conductscience.org/api/trials/v1/NCT00911820/events?page=2