Trial · NCT00305877
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
NCT00305877, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery. Trials, record NCT00305877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00305877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
- NCT number
- NCT00305877
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer
- Interventions
- cetuximab, gemcitabine hydrochloride, capecitabine, radiation therapy, bevacizumab, laboratory biomarker analysis
- First posted
- 2006-03-22
- Last updated
- 2014-05-21
- Results first posted
- 2013-11-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy | Every 2 weeks while on treatment and for 30 days after the end of treatment | Specific toxicities to be monitored pursuant to the primary endpoint include: 1. Any grade 5 toxicities 2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension 3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis 4. ECOG performance status decline by 2 or greater for \>24 hours 5. Weight loss \>10% |
| Secondary | Two-year Overall Survival Rate | Assessed every 3 months for 2 years | Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival. |
| Secondary | Two-year Disease-free Survival (DFS) | Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years | Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy | Every 2 weeks while on treatment and for 30 days after the end of treatment | All treated patients were included in this analysis. | Proportion of patients | NUMBER |
| SECONDARY | Two-year Overall Survival Rate | Assessed every 3 months for 2 years | Eligible and treated patients are included in this analysis. | Proportion of patients | NUMBER |
| SECONDARY | Two-year Disease-free Survival (DFS) | Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years | Eligible and treated patients. | Proportion of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 0.30 | 95% Confidence Interval 0.19 to 0.42 | Proportion of patients | |
| Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 0.25 | 95% Confidence Interval 0.15 to 0.38 | Proportion of patients | |
| Two-year Overall Survival Rate | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 0.38 | 95% Confidence Interval 0.26 to 0.50 | Proportion of patients | |
| Two-year Overall Survival Rate | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 0.37 | 95% Confidence Interval 0.24 to 0.48 | Proportion of patients | |
| Two-year Disease-free Survival (DFS) | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 0.17 | 95% Confidence Interval 0.08 to 0.26 | Proportion of patients | |
| Two-year Disease-free Survival (DFS) | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 0.23 | 95% Confidence Interval 0.12 to 0.34 | Proportion of 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 (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 69 | |
| Overall Study | STARTED | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 68 | |
| Overall Study | Treated | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 67 | |
| Overall Study | Treated | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 63 | |
| Overall Study | Eligible | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 66 | |
| Overall Study | Eligible | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 66 | |
| Overall Study | Included in Efficacy Analysis | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 65 | |
| Overall Study | Included in Efficacy Analysis | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 62 | |
| Overall Study | COMPLETED | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 45 | |
| Overall Study | COMPLETED | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events218
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 (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 28 | 67 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 28 | 63 | |
| other | Leukocytes decreased | Investigations | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 47 | 67 | |
| other | Leukocytes decreased | Investigations | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 39 | 63 | |
| other | Lymphopenia | Investigations | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 12 | 67 | |
| other | Lymphopenia | Investigations | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 4 | 63 | |
| other | Neutrophils decreased | Investigations | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 34 | 67 | |
| other | Neutrophils decreased | Investigations | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 34 | 63 | |
| other | Platelets decreased | Investigations | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 36 | 67 | |
| other | Platelets decreased | Investigations | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 34 | 63 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | ||
| Total, all-cause mortality | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | ||
| Total, other adverse events | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 66 | 67 |
| Total, other adverse events | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 60 | 63 |
| Total, serious adverse events | Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) | 54 | 67 |
| Total, serious adverse events | Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) | 51 | 63 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) vs Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation): 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/NCT00305877
GET https://conductscience.org/api/trials/v1/NCT00305877/events?page=2