CholangiocarcinomaPhase 1NCT00630890
Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)
A Phase 1 study testing External beam radiation and Cyberknife radiosurgery boost and capecitabine in people with Cholangiocarcinoma and Klatskin Tumor, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of giving external beam radiation, followed by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher slowly in this protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Klatskin Tumor, Biliary Tract Cancer
- What is being tested?
- External beam radiation and Cyberknife radiosurgery boost and capecitabine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age eighteen years or older
- Histological defined unresectable cholangiocarcinoma of hilar region of the liver
- Patients should have evaluable disease on one or more imaging modalities (CT scan, MRI, and/or PET) since this will be necessary for radiation treatment planning. However, because the borders of these tumors are sometimes difficult to define precisely, measurable disease is not required (see Section 9.1 for definitions of evaluable and measurable disease).
- The maximum tumor dimension should be less than 6 cm.
- Patients with pathologically enlarged perihepatic regional lymph nodes are allowed.
- Prior surgical resection is allowed if there is gross disease remaining
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- Adjuvant chemotherapy is allowed at least 1 month after completion of radiation therapy if any grade 3 or higher toxicity has resolved
- Percutaneous biliary drains and biliary stents are allowed
- Performance status of ECOG 0-1 (see Appendix I)
- Life expectancy greater than 6 months
- Subject must have normal organ and marrow functions as defined below
- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- total bilirubin <2.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- PT/PTT within normal institutional limits
- Gold marker seeds (1 to 3) are required to be placed in or around the primary tumor by an interventional radiologist
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
- Women of child-bearing potential must agree to use an effective method of birth control during treatment and for six months after receiving their last dose of treatment
Who cannot join
- Patients who have had prior chemotherapy
- Patients who have had external beam radiation to the region of liver hilar previously.
- Patients receiving any other investigational agents
- Patients with known metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Patients who are not candidates for gold marker seeds placement due to position of the tumor or co-existing medical condition.
- Pregnant or lactating women and women of child-bearing potential who are not using an effective method of birth control
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143-0226
About this study
Official title: Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor)
The purpose of this study is to test the safety of giving external beam radiation, followed by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is not amenable for surgical removal, are eligible.
The hypothesis is that highly focused high dose radiation delivered using Cyberknife in conjunction with traditional radiation and chemotherapy can improve outcome in this patient population.
Read the detailed description
This is a dose escalation study which will escalate the dose of Cyberknife radiosurgery boost after external beam radiation of 45 Gy with concurrent capecitabine. The three dose levels are 4 Gy x5, 5 Gy x5 and 6 Gy x 5, with 3 patients at each dose level. Dose-limiting toxicity (DLT) is defined as acute grade 3 liver or intestinal toxicity or any acute grade 4 toxicity. If one patient experienced a DLT at a particular dose level, the cohort should be expanded to 6 patients. The maximum tolerated dose (MTD) is defined as the dose level below that which results in DLT in 2 or more of the 6 patients in each cohort. At least 5 patients should be enrolled in the cohort of 6 Gy x 5 even if none of the first 3 experienced DLT, as a means of added verification of dose tolerance, at this upper limit of dose for this study.
The patient population includes any patients who have unresectable hilar cholangiocarcinoma without any prior history of radiation. We anticipate accruing 1 patient every 2 months; therefore, we estimate that it will require approximately 22 months to accrue 11 patients if no DLT is experienced by any patients requiring expansion of the cohorts.
- Conditions
- Cholangiocarcinoma, Klatskin Tumor, Biliary Tract Cancer
- Being tested
- External beam radiation and Cyberknife radiosurgery boost and capecitabine
- Keywords
- Hilar Cholangiocarcinoma (Klatskin Tumor), External Beam Radiation, Cyberknife, Capecitabine
- Medical subject headings
- Cholangiocarcinoma, Klatskin Tumor, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiation and Cyberknife radiosurgery boost and capecitabineRadiation
Also called Xeloda
External Beam Radiation to 45 Gy Stereotactic Body Radiotherapy with Cyberknife to 20 Gy in 5 fractions dose escalation to 25 Gy in 5 fractions, and then 30 Gy in 5 fractions Capecitabine 825 mg/m2 q12 hours taken orally 5 days per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | External beam radiation with Cyberknife radiosurgery boost and concurrent capecitabine Receives: Radiation: External beam radiation and Cyberknife radiosurgery boost and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate acute toxicities
Measured: 3 months for acute toxicities
To determine the maximal tolerated dose of the Cyberknife radiosurgery boost
Measured: 3 months for acute toxicities
Secondary outcomes (4)
To assess local and regional control
Measured: two years
To evaluate radiographic response
Measured: two years
To assess delayed and long-term toxicities
Measured: two years
To estimate disease specific and overall survival
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: investigator left UCSF and study was closed prematurely in 2008. No results to report.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Huang, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630890
- Sponsor's protocol ID
- 07455
- Status last verified
- Sep 2015
- First submitted
- 28 Feb 2008
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Trial of External Beam Radiation and Cyberknife Radiosurgery Boost With Concurrent Capecitabine for Hilar Cholangiocarcinoma (Klatskin Tumor)
- ClinicalTrials.gov ID
- NCT00630890
- Acronym / sponsor ID
- 07455
- Conditions
- Cholangiocarcinoma, Klatskin Tumor, Biliary Tract Cancer
- Keywords
- Hilar Cholangiocarcinoma (Klatskin Tumor), External Beam Radiation, Cyberknife, Capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator left UCSF and study was closed prematurely in 2008. No results to report.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety of giving external beam radiation, followed by a Cyberknife radiosurgery boost at different dose levels, together with a chemotherapy drug called capecitabine. The dose of Cyberknife radiosurgery boost will be made higher slowly in this protocol. Patients with hilar cholangiocarcinoma (Klatskin tumor), which is not amenable for surgical removal, are eligible.
The hypothesis is that highly focused high dose radiation delivered using Cyberknife in conjunction with traditional radiation and chemotherapy can improve outcome in this patient population.
Detailed description
This is a dose escalation study which will escalate the dose of Cyberknife radiosurgery boost after external beam radiation of 45 Gy with concurrent capecitabine. The three dose levels are 4 Gy x5, 5 Gy x5 and 6 Gy x 5, with 3 patients at each dose level. Dose-limiting toxicity (DLT) is defined as acute grade 3 liver or intestinal toxicity or any acute grade 4 toxicity. If one patient experienced a DLT at a particular dose level, the cohort should be expanded to 6 patients. The maximum tolerated dose (MTD) is defined as the dose level below that which results in DLT in 2 or more of the 6 patients in each cohort. At least 5 patients should be enrolled in the cohort of 6 Gy x 5 even if none of the first 3 experienced DLT, as a means of added verification of dose tolerance, at this upper limit of dose for this study.
The patient population includes any patients who have unresectable hilar cholangiocarcinoma without any prior history of radiation. We anticipate accruing 1 patient every 2 months; therefore, we estimate that it will require approximately 22 months to accrue 11 patients if no DLT is experienced by any patients requiring expansion of the cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: External beam radiation and Cyberknife radiosurgery boost and capecitabineExternal beam radiation with Cyberknife radiosurgery boost and concurrent capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age eighteen years or older
- Histological defined unresectable cholangiocarcinoma of hilar region of the liver
- Patients should have evaluable disease on one or more imaging modalities (CT scan, MRI, and/or PET) since this will be necessary for radiation treatment planning. However, because the borders of these tumors are sometimes difficult to define precisely, measurable disease is not required (see Section 9.1 for definitions of evaluable and measurable disease).
- The maximum tumor dimension should be less than 6 cm.
- Patients with pathologically enlarged perihepatic regional lymph nodes are allowed.
Key exclusion criteria (9 listed)
- Patients who have had prior chemotherapy
- Patients who have had external beam radiation to the region of liver hilar previously.
- Patients receiving any other investigational agents
- Patients with known metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiation and Cyberknife radiosurgery boost and capecitabineAlso: XelodaExternal Beam Radiation to 45 Gy Stereotactic Body Radiotherapy with Cyberknife to 20 Gy in 5 fractions dose escalation to 25 Gy in 5 fractions, and then 30 Gy in 5 fractions Capecitabine 825 mg/m2 q12 hours taken orally 5 days per week | Radiation | 1 |
Primary outcome
To evaluate acute toxicities
Time frame: 3 months for acute toxicities
To determine the maximal tolerated dose of the Cyberknife radiosurgery boost
Time frame: 3 months for acute toxicities
4 secondary outcomes
To assess local and regional control
Time frame: two years
To evaluate radiographic response
Time frame: two years
To assess delayed and long-term toxicities
Time frame: two years
To estimate disease specific and overall survival
Time frame: two years
Results and safety
The study was stopped early (reason given: investigator left UCSF and study was closed prematurely in 2008. No results to report.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Huang, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing External beam radiation and Cyberknife radiosurgery boost and capecitabine in people with Cholangiocarcinoma and Klatskin Tumor, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: investigator left UCSF and study was closed prematurely in 2008. No results to report.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate acute toxicities (time frame: 3 months for acute toxicities). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.