Trial · NCT00033540

S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

NCT00033540, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2012-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma. Trials, record NCT00033540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00033540

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
NCT number: NCT00033540
Status: Completed
Phases: Phase 2
Enrollment: 57 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Interventions: capecitabine, gemcitabine hydrochloride
First posted: 2003-01-27
Last updated: 2017-09-12
Results first posted: 2012-08-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response	Patients assessed at least every six weeks while on protocol treatment	Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Secondary	Overall Survival	All patients will be followed until death or three years after registration, whichever is first.	Measured from time of registration to death, or last contact date
Secondary	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.
Secondary	Accrual of Patients With This Disease Site	1-20 months	Only eligible patients who received treatment were evaluable for response and survival outcomes.
Secondary	Median Survival Time for Participants With Relevant Biologic Markers	All patients will be followed until death or three years after registration, whichever is first.	To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.

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	Response	Patients assessed at least every six weeks while on protocol treatment	All eligible patients who started treatment were included in assessing response estimates.	participants	NUMBER
SECONDARY	Overall Survival	All patients will be followed until death or three years after registration, whichever is first.	All eligible patients who started treatment were included in assessing response estimates.	months	MEDIAN
SECONDARY	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.	Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.	Participants	NUMBER
SECONDARY	Accrual of Patients With This Disease Site	1-20 months	Patients with advanced disease accrued between September 2003 to April 2005	participants	NUMBER
SECONDARY	Median Survival Time for Participants With Relevant Biologic Markers	All patients will be followed until death or three years after registration, whichever is first.	Eligible patients who received genotyping were included in this analysis.	months	MEDIAN

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Response	Capecitabine + Gemcitabine	Confirmed Partial Response	7		participants
Response	Capecitabine + Gemcitabine	Unconfirmed Partial Response	6		participants
Response	Capecitabine + Gemcitabine	Stable Disease	12		participants
Response	Capecitabine + Gemcitabine	Progression	15		participants
Response	Capecitabine + Gemcitabine	Symptomatic Deterioration	3		participants
Response	Capecitabine + Gemcitabine	Early Death	1		participants
Response	Capecitabine + Gemcitabine	Inadequate Assessment	8		participants
Overall Survival	Capecitabine + Gemcitabine		7	95% Confidence Interval 5 to 8	months
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Gemcitabine and Capecitabine	ALT, SGPT (serum glutamic pyruvic transaminase)	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Gemcitabine and Capecitabine	AST,SGOT (serum glutamic oxaloacetic transaminase)	5		Participants

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow5

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Capecitabine + Gemcitabine	57
Overall Study	Eligible	Capecitabine + Gemcitabine	54
Overall Study	Eligible and Began Protocol Therapy	Capecitabine + Gemcitabine	52
Overall Study	COMPLETED	Capecitabine + Gemcitabine	0
Overall Study	NOT COMPLETED	Capecitabine + Gemcitabine	57

Source ClinicalTrials.gov

Adverse events66

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
other	Hemoglobin	Blood and lymphatic system disorders	Gemcitabine and Capecitabine	42	51
other	Ocular surface disease	Eye disorders	Gemcitabine and Capecitabine	3	51
other	Ascites (non-malignant)	Gastrointestinal disorders	Gemcitabine and Capecitabine	4	51
other	Constipation	Gastrointestinal disorders	Gemcitabine and Capecitabine	21	51
other	Diarrhea	Gastrointestinal disorders	Gemcitabine and Capecitabine	17	51
other	Heartburn/dyspepsia	Gastrointestinal disorders	Gemcitabine and Capecitabine	4	51
other	Mucositis/stomatitis (clinical exam) - Oral cavity	Gastrointestinal disorders	Gemcitabine and Capecitabine	11	51
other	Mucositis/stomatitis (functional/symp) - Oral cav	Gastrointestinal disorders	Gemcitabine and Capecitabine	6	51
other	Nausea	Gastrointestinal disorders	Gemcitabine and Capecitabine	32	51
other	Pain - Abdomen NOS	Gastrointestinal disorders	Gemcitabine and Capecitabine	18	51

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gemcitabine and Capecitabine
Total, other adverse events	Gemcitabine and Capecitabine	51	51
Total, serious adverse events	Gemcitabine and Capecitabine	7	51

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18192902	BACKGROUND	PubMed
21556747	RESULT	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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