TriangleNCT00789958 · STUDY IN CONTEXT
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
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.
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.
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.
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).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- trial label
- S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0000
- source section id
- NCT00789958-om-0000
- source outcome index
- 0
- endpoint
- Stratum-specific (R0 and R1) 2-year Overall Survival
- endpoint definition
- 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.
- time origin
- Up to 2 years from registration
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and analyzable patients that received protocol treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0001
- source section id
- NCT00789958-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
- endpoint definition
- Only adverse events that are possibly, probably or definitely related to study drug are reported.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0002
- source section id
- NCT00789958-om-0002
- source outcome index
- 2
- endpoint
- 2-year Overall Survival for All Patients
- endpoint definition
- 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.
- time origin
- Up to 2 years from registration
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and analyzable patients that received protocol treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0003
- source section id
- NCT00789958-om-0003
- source outcome index
- 3
- endpoint
- 2-year Stratum-specific Disease-free Survival
- endpoint definition
- 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.
- time origin
- Up to 2 years from registration
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and analyzable patients that received protocol treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0004
- source section id
- NCT00789958-om-0004
- source outcome index
- 4
- endpoint
- 2-year Disease-free Survival in All Patients
- endpoint definition
- 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.
- time origin
- Up to 2 years from registration
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and analyzable patients that received protocol treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0005
- source section id
- NCT00789958-om-0005
- source outcome index
- 5
- endpoint
- 2-year Stratum-specific Local Relapse Rate
- endpoint definition
- 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).
- time origin
- Up to 2 years from registration
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and analyzable patients that received protocol treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Patients With Negative Margins of Resection (R0)
- regimen
- Eligible and analyzable patients that received a resection with negative (R0) margins.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Patients w/Microscopically Positive Margin of Resection (R1)
- regimen
- Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Adjuvant Chemotherapy + Chemoradiotherapy
- regimen
- Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Adjuvant Chemotherapy + Chemoradiotherapy
- regimen
- Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Patients With Negative Margins of Resection (R0)
- regimen
- Eligible and analyzable patients that received a resection with negative (R0) margins.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Patients w/Microscopically Positive Margin of Resection (R1)
- regimen
- Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Adjuvant Chemotherapy + Chemoradiotherapy
- regimen
- Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Patients With Negative Margins of Resection (R0)
- regimen
- Eligible and analyzable patients that received a resection with negative (R0) margins.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Patients w/Microscopically Positive Margin of Resection (R1)
- regimen
- Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00789958-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gallbladder-cancer
- nct id
- NCT00789958
- harm key
- EG000
- source section id
- NCT00789958-ae
- event group key
- EG000
- event group label
- Adjuvant Chemotherapy + Chemoradiotherapy
- serious affected
- 2
- serious at risk
- 79
- other affected
- 78
- other at risk
- 79
- frequency threshold
- 5
- collection period
- Up to 5 years
- event definition
- Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice