Trial · NCT00660699
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
NCT00660699, Phase 2, Completed, Washington University School of Medicine; results first posted 2015-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers. Trials, record NCT00660699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00660699
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
- NCT number
- NCT00660699
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer, Ampullary Cancer
- Interventions
- Gemcitabine, Docetaxel, Radiation
- First posted
- 2008-04-17
- Last updated
- 2015-05-27
- Results first posted
- 2015-05-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Severe Toxicities | 1 month after completion of treatment (treatment lasts approximately 19 weeks) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 |
| Secondary | Toxicities Associated With Treatment (Grade 1-2) | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome. |
| Secondary | Toxicities Associated With Treatment (Grade 3-4) | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome. |
| Secondary | Disease Free Survival (DFS) - Median | Median follow-up was 24 months (range 3.2-97 months) | DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. |
| Secondary | Overall Survival (OS) - Median | Median follow-up was 24 months (range 3.2-97 months) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. |
| Secondary | Overall Survival (OS) | 1 year | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up |
| Secondary | Overall Survival (OS) | 2 years | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Severe Toxicities | 1 month after completion of treatment (treatment lasts approximately 19 weeks) | percentage of participants | NUMBER | |
| SECONDARY | Toxicities Associated With Treatment (Grade 1-2) | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | percentage of participants | NUMBER | |
| SECONDARY | Toxicities Associated With Treatment (Grade 3-4) | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | percentage of participants | NUMBER | |
| SECONDARY | Disease Free Survival (DFS) - Median | Median follow-up was 24 months (range 3.2-97 months) | months | MEDIAN | |
| SECONDARY | Disease Free Survival (DFS) - Median | Median follow-up was 24 months (range 3.2-97 months) | 30 out of 48 participants completed all components of the study therapy. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Median | Median follow-up was 24 months (range 3.2-97 months) | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 1 year | percentage of participants | NUMBER | |
| POST_HOC | Incidence of Disease Recurrence | Median follow-up was 24 months (range 3.2-97 months) | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) - Median | Median follow-up was 24 months (range 3.2-97 months) | 30 out of 48 participants completed all components of study treatment. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Severe Toxicities | Arm 1 | 20 | percentage of participants | ||
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Mucositis | 31 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Nausea | 48 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Vomiting | 23 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Diarrhea | 31 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Dehydration | 17 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Weight loss | 27 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Fatigue | 67 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Renal toxicity | 13 | percentage of participants | |
| Toxicities Associated With Treatment (Grade 1-2) | Arm 1 | Hepatotoxicity | 69 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) | 50 | |
| Overall Study | COMPLETED | Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) | 48 | |
| Overall Study | NOT COMPLETED | Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) | 2 |
Source ClinicalTrials.gov
Adverse events95
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 | Alkaline phosphatase | Investigations | Arm 1 | 18 | 48 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm 1 | 2 | 48 | |
| other | Anorexia | Metabolism and nutrition disorders | Arm 1 | 11 | 48 | |
| other | Anxiety | Psychiatric disorders | Arm 1 | 1 | 48 | |
| other | Ascites | Gastrointestinal disorders | Arm 1 | 2 | 48 | |
| other | BUN | Investigations | Arm 1 | 2 | 48 | |
| other | Bilirubin | Investigations | Arm 1 | 1 | 48 | |
| other | Chills | General disorders | Arm 1 | 2 | 48 | |
| other | Colitis | Gastrointestinal disorders | Arm 1 | 1 | 48 | |
| other | Constipation | Gastrointestinal disorders | Arm 1 | 8 | 48 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, other adverse events | Arm 1 | 48 | 48 |
| Total, serious adverse events | Arm 1 | 16 | 48 |
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 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/NCT00660699
GET https://conductscience.org/api/trials/v1/NCT00660699/results?page=2