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NCT00789958 · ClinicalTrials.gov registry record · Phase 2

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

A Phase 2 study, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 2
Development phase
105
Enrollment target

NCT00789958: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.

NCT00789958 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00789958, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 2
Development phase
105 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.

Primary Outcome

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.

Interventions

  • RADIATION intensity-modulated radiation therapy
  • DRUG capecitabine
  • RADIATION 3-dimensional conformal radiation therapy
  • DRUG gemcitabine hydrochloride

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2008-12
Est. Completion 2017-12
Phase Phase 2
SWOG Cancer Research Network

270 total trials

What the finished NCT00789958 record still lists

NCT00789958 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).

The record links to 0 conditions, and to 4 interventions - of which intensity-modulated radiation therapy is the first listed.

NCT00789958 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00789958 about?

NCT00789958 is a clinical study titled "S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct". RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that deli...

What is the current status of trial NCT00789958?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2008-12. Estimated completion is 2017-12.

What interventions are being tested in trial NCT00789958?

The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), capecitabine (DRUG), 3-dimensional conformal radiation therapy (RADIATION), gemcitabine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00789958?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00789958's enrollment target sits among peer trials

105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00789958, the US trial registry maintained by the National Library of Medicine. NCT00789958 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.