Unresectable Intrahepatic CholangiocarcinomaNCT02256982
A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma
A study testing Gemcitabine, Cisplatin and Surgery in people with Unresectable Intrahepatic Cholangiocarcinoma and Resectable Intrahepatic Cholangiocarcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is evaluating the use of radiation therapy in combination with chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Intrahepatic Cholangiocarcinoma, Resectable Intrahepatic Cholangiocarcinoma
- What is being tested?
- Gemcitabine, Cisplatin and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2016
- Phase
- Interventional
- 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
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically confirmed Intrahepatic Cholangiocarcinoma (IHC) without evidence of extrahepatic metastasis.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan.
- Participants with resectable disease must have a single tumor (with no satellite lesions) with a total diameter or longest dimension of ≤ 20cm. Patients with unresectable disease must have a total tumor diameter of <20cm and ≤ 3 lesions. Satellite lesions defined as lesions ≤ 2cm from the dominant lesion are permitted for participants with unresectable disease
- Patients are not allowed to receive prior surgery or chemotherapy for the IHC.
- Patients with age ≥18 will be included in the study.
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- Expected survival must be three months or greater.
- ECOG performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix A).
- Participants must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 2.5 mg/dl
- AST (SGOT)/ALT (SGPT) ≤ 5.0 X institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal .
- No other known active secondary primary malignancy.
- If patient has underlying cirrhosis, only Child-Pugh classification Group A patients may be included in the resectable cohort of this study. For patients with unresectable disease, Child-Pugh classification Groups A and B are allowed. Clinical assessment of ascites and encephalopathy is required. Child-Pugh classification must be determined for all study participants at the time of eligibility analysis. Note albumin and PT/INR are required for Child-Pugh classification; these labs should be drawn with the other labs required for eligibility analysis.
- Table 1: Child-Pugh classification of liver function
- Score 1 2 3
- Ascites Absent Slight to moderate Severe
- Encephalopathy Absent Slight to moderate Severe
- Serum albumin >3.5 g/dl 3-3.5 g/dl <3 g/dl
- Serum bilirubin <2 mg/dl 2-3 mg/dl >3 mg/dl
- Prolongation of prothrombin time <4 seconds 4-6 seconds >6 seconds
- Score of 5 to 6 corresponds to Child-Pugh class A
- Score of 7 to 11 corresponds to Child-Pugh class B
- Score of 12 to 15 corresponds to Child-Pugh class
- The effects of gemcitabine+cisplatin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Female patients of child bearing potential must indicate to their physician that they are not pregnant at the time of enrollment or have a negative serum pregnancy test.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy or radiotherapy for intrahepatic cholangiocarcinoma.
- Participants receiving any other anti-cancer or investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or cisplatin.
- Women who are pregnant or lactating.
- Participants with evidence of non-hepatic metastatic disease.
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- Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
- Participants with a serious medical illness which may limit expected survival to less than 3 months.
- Participants with serious psychiatric illness or social situations which would limit adherence to study requirements.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible.
- Because no dosing or adverse event data are currently available on the use of gemcitabine+cisplatin in participants <18 years of age, children are excluded from this study.
- Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin.
- 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.
- Pregnant women are excluded from this study because gemcitabine is a class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, DCIS, stage I prostate cancer, and basal cell or squamous cell carcinoma of the skin.
- HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with gemcitabine+cisplatin. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. HIV-positive individuals on HAART will be considered eligible of they have demonstrated good compliance and have a CD4 count > 500.
- Prior liver directed radiation.
- Patients with peripheral neuropathy ≥ grade 2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This research study is evaluating the use of radiation therapy in combination with chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of gastrointestinal cancer.
Read the detailed description
This study is to assess the possibility of using radiation therapy to treat intrahepatic cholangiocarcinoma. Radiation therapy is used for many other types of malignancies, but its use for the treatment of this form of gastrointestinal cancer has been limited. This treatment is still being studied as research doctors are trying to find out more about its use in the treatment of your form of gastrointestinal cancer. Short course photon radiation and short course proton beam radiation therapies are FDA (U.S. Food and Drug Administration) approved radiation delivery systems. This study will also test the safety of neoadjuvant chemotherapy versus adjuvant chemotherapy. Neoadjuvant therapy is treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Adjuvant therapy is additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.
The current standard of care for patients with intrahepatic cholangiocarcinoma is to offer surgical resection to all patients who have resectable disease and are able to tolerate a major surgical intervention.
The study interventions involved this trial may include one or more of the following:
- Chemotherapy (Gemcitabine and Cisplatin)
- Surgical Resection and Lymphadenectomy
- Radiation Therapy
- Being tested
- Gemcitabine, Cisplatin, Surgery, Radiation
- Keywords
- unresectable intrahepatic cholangiocarcinoma, resectable intrahepatic cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
CisplatinDrug
Also called Platinol®, Platinol-AQ®, cis-DDP, cis-Platinum II
SurgeryProcedure or surgery
Surgical Resection and Lymphadenectomy
RadiationRadiation
Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Resectable Disease | Experimental | * Consent and Registration
* 3 cycles of gemcitabine + cisplatin
* Evaluate for surgery* (weeks 10-15)
-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
* Proceed to surgery
* Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist Receives: Drug: Gemcitabine; Drug: Cisplatin; Procedure: Surgery |
| Unresectable Disease | Experimental | * Consent and Registration
* 3 cycles of gemcitabine + cisplatin
* Evaluate for surgery* (weeks 10-15)
* Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.
* Proceed to radiation therapy with protons or photons, determined by available resources
* Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist Receives: Drug: Gemcitabine; Drug: Cisplatin; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Post Operative/Radiation Therapy Complications
Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unresectable Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Sunki Hong, Massachusetts General Hospital
- Investigators
- Theodore S. Hong, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256982
- Sponsor's protocol ID
- 14-275
- Status last verified
- Apr 2016
- First submitted
- 25 Sep 2014
- Last updated
- 13 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02256982
- Acronym / sponsor ID
- 14-275
- Keywords
- unresectable intrahepatic cholangiocarcinoma, resectable intrahepatic cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Posted 13 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the use of radiation therapy in combination with chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of gastrointestinal cancer.
Detailed description
This study is to assess the possibility of using radiation therapy to treat intrahepatic cholangiocarcinoma. Radiation therapy is used for many other types of malignancies, but its use for the treatment of this form of gastrointestinal cancer has been limited. This treatment is still being studied as research doctors are trying to find out more about its use in the treatment of your form of gastrointestinal cancer. Short course photon radiation and short course proton beam radiation therapies are FDA (U.S. Food and Drug Administration) approved radiation delivery systems. This study will also test the safety of neoadjuvant chemotherapy versus adjuvant chemotherapy. Neoadjuvant therapy is treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Adjuvant therapy is additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.
The current standard of care for patients with intrahepatic cholangiocarcinoma is to offer surgical resection to all patients who have resectable disease and are able to tolerate a major surgical intervention.
The study interventions involved this trial may include one or more of the following:
- Chemotherapy (Gemcitabine and Cisplatin)
- Surgical Resection and Lymphadenectomy
- Radiation Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable Disease | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Procedure: Surgery* Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery* (weeks 10-15) -- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to surgery * Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist |
| Unresectable Disease | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Radiation: Radiation* Consent and Registration * 3 cycles of gemcitabine + cisplatin * Evaluate for surgery* (weeks 10-15) * Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy. * Proceed to radiation therapy with protons or photons, determined by available resources * Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically confirmed Intrahepatic Cholangiocarcinoma (IHC) without evidence of extrahepatic metastasis.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan.
- Participants with resectable disease must have a single tumor (with no satellite lesions) with a total diameter or longest dimension of ≤ 20cm. Patients with unresectable disease must have a total tumor diameter of <20cm and ≤ 3 lesions. Satellite lesions defined as lesions ≤ 2cm from the dominant lesion are permitted for participants with unresectable disease
- Patients are not allowed to receive prior surgery or chemotherapy for the IHC.
Key exclusion criteria (18 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy or radiotherapy for intrahepatic cholangiocarcinoma.
- Participants receiving any other anti-cancer or investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or cisplatin.
- Women who are pregnant or lactating.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | Resectable Disease, Unresectable Disease |
| CisplatinAlso: Platinol®, Platinol-AQ®, cis-DDP, cis-Platinum II | Drug | Resectable Disease, Unresectable Disease |
| SurgerySurgical Resection and Lymphadenectomy | Procedure or surgery | Resectable Disease |
| RadiationRadiation Therapy | Radiation | Unresectable Disease |
Primary outcome
Number of Participants Post Operative/Radiation Therapy Complications
Time frame: 90 Days
Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Theodore S. Hong, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemcitabine, Cisplatin and Surgery in people with Unresectable Intrahepatic Cholangiocarcinoma and Resectable Intrahepatic Cholangiocarcinoma, run by Massachusetts General Hospital 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 29 inclusion and 18 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 13 Apr 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 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?
Number of Participants Post Operative/Radiation Therapy Complications (time frame: 90 Days). 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 13 Apr 2016.