Trial · NCT00789958
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
NCT00789958, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2016-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct. Trials, record NCT00789958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00789958
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
- NCT number
- NCT00789958
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer
- Interventions
- capecitabine, gemcitabine hydrochloride, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
- First posted
- 2008-11-13
- Last updated
- 2018-04-09
- Results first posted
- 2016-09-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stratum-specific (R0 and R1) 2-year Overall Survival | Up to 2 years from registration | Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 5 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | 2-year Overall Survival for All Patients | Up to 2 years from registration | Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | 2-year Stratum-specific Disease-free Survival | Up to 2 years from registration | Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | 2-year Disease-free Survival in All Patients | Up to 2 years from registration | Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | 2-year Stratum-specific Local Relapse Rate | Up to 2 years from registration | Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). |
| Secondary | 2-year Overall Local Relapse Rate | Up to 2 years from registration | Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stratum-specific (R0 and R1) 2-year Overall Survival | Up to 2 years from registration | Eligible and analyzable patients that received protocol treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 5 years | Eligible patients who received any treatment and were assessed for adverse events are included in this summary. | Participants | NUMBER |
| SECONDARY | 2-year Overall Survival for All Patients | Up to 2 years from registration | Eligible and analyzable patients that received protocol treatment. | percentage of participants | NUMBER |
| SECONDARY | 2-year Stratum-specific Disease-free Survival | Up to 2 years from registration | Eligible and analyzable patients that received protocol treatment. | percentage of participants | NUMBER |
| SECONDARY | 2-year Disease-free Survival in All Patients | Up to 2 years from registration | Eligible and analyzable patients that received protocol treatment. | percentage of participants | NUMBER |
| SECONDARY | 2-year Stratum-specific Local Relapse Rate | Up to 2 years from registration | Eligible and analyzable patients that received protocol treatment. | percentage of participants | NUMBER |
| SECONDARY | 2-year Overall Local Relapse Rate | Up to 2 years from registration | Eligible and analyzable patients that received protocol treatment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stratum-specific (R0 and R1) 2-year Overall Survival | Patients With Negative Margins of Resection (R0) | 67 | 95% Confidence Interval 52 to 78 | percentage of participants | |
| Stratum-specific (R0 and R1) 2-year Overall Survival | Patients w/Microscopically Positive Margin of Resection (R1) | 60 | 95% Confidence Interval 38 to 76 | percentage of participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Anorexia | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Cardiac troponin I (cTnI) | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Constipation | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Dehydration | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Diarrhea | 6 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Fatigue (asthenia, lethargy, malaise) | 4 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Febrile neutropenia | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adjuvant Chemotherapy + Chemoradiotherapy | Hemoglobin | 1 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adjuvant Chemotherapy + Chemoradiotherapy | 105 | |
| Overall Study | Eligible and Analyzable | Adjuvant Chemotherapy + Chemoradiotherapy | 79 | |
| Overall Study | COMPLETED | Adjuvant Chemotherapy + Chemoradiotherapy | 68 | |
| Overall Study | NOT COMPLETED | Adjuvant Chemotherapy + Chemoradiotherapy | 37 |
Source ClinicalTrials.gov
Adverse events56
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 | Low hemoglobin level | Blood and lymphatic system disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 45 | 79 | |
| other | Constipation | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 24 | 79 | |
| other | Diarrhea | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 35 | 79 | |
| other | Distention/bloating, abdominal | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 8 | 79 | |
| other | Flatulence | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 4 | 79 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 7 | 79 | |
| other | Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 17 | 79 | |
| other | Mucositis/stomatitis (functional/symp) - Oral cav | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 10 | 79 | |
| other | Nausea | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 49 | 79 | |
| other | Pain - Abdomen NOS | Gastrointestinal disorders | Adjuvant Chemotherapy + Chemoradiotherapy | 24 | 79 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adjuvant Chemotherapy + Chemoradiotherapy | ||
| Total, other adverse events | Adjuvant Chemotherapy + Chemoradiotherapy | 78 | 79 |
| Total, serious adverse events | Adjuvant Chemotherapy + Chemoradiotherapy | 2 | 79 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25964250 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00789958
GET https://conductscience.org/api/trials/v1/NCT00789958/results?page=2