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CholangiocarcinomaPhase 2NCT01151761

Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

A Phase 2 study testing Stereotactic Body Radiotherapy, Gemcitabine and Cisplatin in people with Cholangiocarcinoma and Hepatobiliary Neoplasm, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic Body Radiotherapy, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jan 2011to Jul 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of cholangiocarcinoma by any of the below:
  • Positive transcatheter biopsy or brush cytology
  • CA 19-9 \≥ 100mg/mL with a malignant-appearing stricture on cholangiography
  • Biliary ploidy by fluorescent in situ hybridization with a malignant stricture on cholangiography
  • Liver tumors not to exceed 8 cm in greatest axial dimension (800 cc of uninvolved liver)
  • Unresectable tumor above cystic duct
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  • Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure by any of the below:
  • Bilateral segmental ductal extension
  • Encasement of the main portal vein
  • Unilateral segmental ductal extension with contralateral vascular encasement
  • Unilateral atrophy with either contralateral segmental ductal or vascular (hepatic artery, portal vein) involvement
  • Ascites is allowed if the Model for End-Stage Liver Disease (MELD) score is <15[1]
  • Age > 18 years old
  • Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)
  • Lab values within 2 wks prior to randomization:
  • See STUDY SCHEMA for specific blood count inclusion criteria: ANC \&#8805; 500 x 109/L (\&#8805; 1500/mm3), Platelets \&#8805; 5 x 109/L (\&#8805; 50,000/mm3), Hgb \&#8805; 9g/dL
  • Adequate liver function: Total bilirubin \&#8804;1.5 x upper limit of normal (ULN); ALT and/or AST \& alkaline phosphatase \&#8804; 5 x ULN.
  • Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible).
  • See STUDY SCHEMA for specific renal function inclusion criteria: Adequate renal function with a calculated GFR \&#8805; 40 ml/min. If the calculated GFR is below 40 ml/min a 24 hour urine creatinine clearance can be used.
  • Albumin > 2.5 mg/dL
  • INR \&#8804; 1.5
  • Life expectancy > 6 months
  • Capable of giving written informed consent

Who cannot join

  • Prior radiotherapy to the upper abdomen
  • Contraindication to receiving radiotherapy
  • Prior chemotherapy
  • Prior biliary resection or attempted resection
  • Prior transperitoneal biopsy
  • Large esophageal varices without band ligation
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  • Active GI bleed or within 2 weeks of study enrollment
  • Ascites refractory to medical therapy or shunting
  • Active/unresolved biliary tract obstruction
  • Presence of multifocal, lymphatic, or extrahepatic metastases
  • Participation in another concurrent treatment protocol
  • If history of other primary cancer, subject eligible only if she or he has:
  • Curatively resected non-melanomatous skin cancer
  • Curatively treated cervical carcinoma in situ
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
  • Any psychiatric or other disorder (eg brain metastases) likely to impact on informed consent
  • Pregnancy or breast-feeding
  • While not excluded, patients with significant impaired hearing must be made aware of potential ototoxicity and may choose not to be included. If included, baseline audiograms are recommended and, in those given cisplatin, should be followed by repeat audiograms prior to cycle 2.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA).

Read the detailed description

Investigators hope to learn more about neoadjuvant SBRT and chemotherapy for unresectable CCA, and if SBRT followed by chemotherapy can lead to successful liver transplantation. This knowledge is important for this patient group as this disease is a highly lethal malignancy that often presents as unresectable, however surgery or transplantation are the only curative options.

Being tested
Stereotactic Body Radiotherapy, Gemcitabine, Cisplatin, Carboplatin, Capecitabine
Medical subject headings
Cholangiocarcinoma, Liver Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body RadiotherapyProcedure or surgery

    Also called External photon radiation

    Standard of care

  • GemcitabineDrug

    Also called Gemzar

    100 mg/m2, IV

  • CisplatinDrug

    Also called Platinol, Platinol-AQ

    25 mg/m2, IV

  • CarboplatinDrug

    Also called Paraplatin, Paraplatin-AQ

    AUC 2, based on Calvert formula, IV

  • CapecitabineDrug

    Also called Xeloda

    1000 mg/m2, PO

  • 5FUDrug

    Also called Fluorouracil, Adrucil, Carac, Efudix

    200 mg/m2

  • Liver transplantationProcedure or surgery

Study groups in NCT01151761
Study groupRoleWhat they receive
SBRT, Chemo and Liver TransplantationExperimentalThe patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
Receives: Procedure: Stereotactic Body Radiotherapy; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin; Drug: Capecitabine; Drug: 5FU; Procedure: Liver transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival at 12 Months

    Progression free survival is defined to be the time to progression of disease or death.

    Measured: 12 months

Secondary outcomes (7)

  1. Pathologic Complete Response Rate

    Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.

    Measured: 12 months

  2. Serum CA 19-9 Levels

    Initial level of Cancer antigen 19-9

    Measured: 12 months

  3. Overall Survival at 12 Months

    the estimated probability for the percentage of participants with overall survival at 12 months.

    Measured: 12 months

  4. Liver Transplant Rate

    The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm

    Measured: 12 months

  5. Freedom From Local Progression at 12 Months

    the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk

    Measured: 12 months

  6. Liver Transplant Conversion Rate

    The ability to successfully perform liver transplant among patients who initially have tumor >3 cm

    Measured: 12 months

  7. Median Time to Overall Survival

    The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2012
  4. Study completionJul 2012

Why it stopped: Poor accrual

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151761
Sponsor's protocol ID
HEP0032
Other IDs
HEP0032
Status last verified
Jun 2016
First submitted
15 Jun 2010
Last updated
29 Jul 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Body Radiotherapy, Gemcitabine and Cisplatin in people with Cholangiocarcinoma and Hepatobiliary Neoplasm, run by Stanford University 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 23 inclusion and 19 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 29 Jul 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151761.

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 29 Jul 2016.

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