AzTrials
AzTrials

Hepatocellular CarcinomaPhase 1NCT01801163

A Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) Plus Sorafenib in Patients With Unresectable Hepatocellular Carcinoma (HCC)

A Phase 1 study testing Sorafenib and Stereotactic radiotherapy in people with Hepatocellular Carcinoma, run by Indiana University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a research study of a radiation treatment called stereotactic body radiotherapy (SBRT) plus a medicine called sorafenib. The purpose of this study is to evaluate the safety of SBRT plus Sorafenib to see what effects (good and bad) it has on the treatment of liver cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sorafenib and Stereotactic radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2012to Oct 2014
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

  • 4.1.1Age ≥ 18 years. 4.1.2 Patients with HCC without cirrhosis or with CTP class A (maximum score 6).
  • 4.1.3 Patient must not be a surgical candidate at presentation. 4.1.4 Able to undergo contrast enhanced MRI of the primary tumor using the liver MRI protocol.
  • 4.1.5 Measurable disease per mRECIST criteria defined as lesions >/=1cm showing intratumoral arterial enhancement in contrast-enhanced CT or MRI and being suitable for repeat measurements.
  • 4.1.6 Must not have evidence of metastatic disease. 4.1.7 Karnofsky performance status >/=70% 4.1.8 Life expectancy ≥ 3 months as determined by the treating physician. 4.1.9 If single tumor, maximum tumor diameter must be </= 6 cm. 4.1.10 No more than three discrete liver lesions, with the overall sum of diameters being </= 6 cm.
  • 4.1.11 None of the lesions to be treated can be in closer than 0.5 cm to the wall of the stomach, duodenum, or hepatic flexure of the colon.
  • 4.1.12 Radiotherapy treatment planning confirms one of the following:
Show all 24Show fewer
  • One third of the uninvolved liver should receive </=10 Gy
  • At least 500 cc of uninvolved liver should receive </=7 Gy 4.1.13 Radiotherapy treatment planning confirms all of the following parameters for other normal tissues tolerance:
  • Maximal cord dose: 600 cGy per fraction x3 for a total of 18 Gy.
  • Right kidney: <2/3 of the kidney volume receives > 15 Gy total dose and
  • Left Kidney: < 1/3 receives > 15 Gy total dose. 4.1.14 Must fit in the stereotactic body immobilization device as per institutional or manufacturer guidelines.
  • 4.1.15 Patients must have adequate liver function within 2 weeks of study registration. Adequate liver function is defined as all of the following:
  • total bilirubin < 3mg/dL
  • albumin >/= 2.5 g/dL
  • INR </= 1.5 and
  • no greater than mild elevation of transaminases (AST, ALT < 5 x ULN) 4.1.16 Patients must have adequate renal function within 2 weeks of study registration. Adequate renal function is defined as one of the following:
  • creatinine < 1.8 mg/dl or
  • creatinine clearance (CrCL) >/= 50 ml/min. 4.1.17 Adequate bone marrow reserve within 2 weeks of study registration, defined as all of the following:
  • ANC count >/=1500 mm3
  • Platelets >/=50,000/mm3
  • Hemoglobin > 9g/dL 4.1.18 No history of atherosclerotic coronary artery disease that required bypass surgery, unless 1) bypass surgery occurred more than 12 months prior to enrollment, and 2) disease is stable (in consultation with a cardiologist).
  • 4.1.19 Women must not be pregnant or breastfeeding. The effects of Sorafenib on the developing human fetus are unknown. For this reason and because radiation therapy and Sorafenib used in this trial are may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • 4.1.20 No history of HIV positivity, as the effects of sorafenib combined with radiation therapy on patients with HIV are unknown. Patients with known HIV risk factors (as determined by the treating physician) will be not eligible for this study without HIV testing.
  • 4.1.21 Must be able to provide written informed consent and HIPAA authorization.

Who cannot join

  • 4.2.1 Medical history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma.
  • 4.2.2 Prior radiation therapy to the abdomen 4.2.3 Prior treatment with Sorafenib or other Ras or VEGF pathway inhibitor. 4.2.4 Minor surgical procedure (e.g fine needle aspiration or needle biopsy) within 7 days of study registration.
  • 4.2.5 Major surgical procedure, significant traumatic injury, or serious non-healing wound, ulcer or bone fracture within 21 days of study registration; investigator has to document adequate healing has occurred prior to study registration.
  • 4.2.6 Any of the following within 6 months prior to study drug administration: severe/unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction, congestive heart failure, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • 4.2.7 History of thrombotic or embolic events such as cerebrovascular accident or transient ischemic attack within the past 6 months.
  • 4.2.8 History of aneurysm or arteriovenous malformation. 4.2.9 Active, clinically serious infection >/= CTCAE grade 2. 4.2.10 Receipt of any investigational agent within 4 weeks of study registration.
Show all 11Show fewer
  • 4.2.11 Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management 4.2.12 Pulmonary hemorrhage/bleeding event ≥CTCAE Grade 2 within 4 weeks of study registration 4.2.13 Any other hemorrhage/bleeding event including esophageal variceal bleeding >/= CTCAE Grade 3 within 4 weeks of study registration.
  • 4.2.14 Evidence or history of bleeding diathesis or coagulopathy 4.2.15 Chronic, daily treatment with nonsteroidal anti-inflammatory medications. (Daily aspirin use is permitted) 4.2.16 Use of carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), rifabutin (Mycobutin), rifampin/ rifampicin (Rifadin, Rimactane), or ritonavir (Norvir).
  • 4.2.17 Known or suspected allergy to Sorafenib or any agent given in the course of this trial.
  • 4.2.18 Any condition that impairs patient's ability to swallow whole pills. 4.2.19 Any malabsorption problem that would impair the patient's ability to absorb oral medication.
  • 4.2.20 Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Phase Ib Study of Stereotactic Radiotherapy (SBRT) Plus Sorafenib in Patients With Unresectable Hepatocellular Carcinoma (HCC)

This is a research study of a radiation treatment called stereotactic body radiotherapy (SBRT) plus a medicine called sorafenib. The purpose of this study is to evaluate the safety of SBRT plus Sorafenib to see what effects (good and bad) it has on the treatment of liver cancer.

Being tested
Sorafenib, Stereotactic radiotherapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • SorafenibDrug

    Sorafenib x 2 weeks followed by Stereotactic Radiotherapy and then sorafenib until disease progression.

  • Stereotactic radiotherapyRadiation

    Sorafenib x 2 weeks followed by Stereotactic Radiotherapy then Sorafenib until disease progression.

Study groups in NCT01801163
Study groupRoleWhat they receive
Sorafenib plus Stereotactic RadiotherapyExperimentalSingle agent Sorafenib x 2 weeks followed by Stereotactic Radiotherapy, then Sorafenib until disease progression.
Receives: Drug: Sorafenib; Radiation: Stereotactic radiotherapy

What is being measured

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

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: Start of sorafenib through disease progression, an expected average of 12 months.

Secondary outcomes (3)

  1. Number of patients with local response

    The local response rate, local clinical benefit rate,and local tumor shrinkage rate (LCR+LPR+LSD's)will be tabulated. Response will be measured according to a modification of the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

    Measured: Start of sorafenib through disease progression, an expected average of 12 months

  2. Time from the start of the treatment until the criteria for overall disease progression is met or death occurs.

    Measured: Start of sorafenib through disease progression, an expected average of 12 months.

  3. Time from start of treatment until death from any cause or date of last patient contact.

    Measured: Start of soafenib until death.

Timeline

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

  1. First posted28 Feb 2013 (estimated)
  2. Study startFeb 2012
  3. Primary completionAug 2014
  4. Study completionOct 2014

Why it stopped: Trial had no patients accrued while open

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01801163
Sponsor's protocol ID
IUCRO-0404
Other IDs
IRB #1211009970
Status last verified
Apr 2015
First submitted
25 Feb 2013
Last updated
16 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sorafenib and Stereotactic radiotherapy in people with Hepatocellular Carcinoma, run by Indiana 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 24 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 Apr 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 withdrawn before enrolling participants, so there are no results.

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 with Adverse Events as a Measure of Safety and Tolerability (time frame: Start of sorafenib through disease progression, an expected average of 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 NCT01801163.

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 16 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in