MDACC Study Summary 2009-0556

Study Summary
No. 2009-0556:.......Gastrointestinal......Christopher H. Crane......Radiation Oncology

Study Summary Title



Study Summary Number:	2009-0556

Study Title:	Phase II Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma

Physician

New Patient Referral



Name:	Christopher H. Crane	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal	Supported By:	National Institutes of Health

Phase of Study:	Phase II	Return Visit:	Weekly on-study labs are to be drawn on study days 1, 8, 15 and the day of the last radiation treatment. All patients will be evaluated initially and every three months for two years, and every 6 months thereafter for 3 years.

Treatment Agents:	Proton Therapy	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if proton beam radiation therapy can shrink or slow the growth of the disease in patients with liver cancer. The safety of this treatment will also be studied.

Study Objectives / Outcomes

Study Design
This is a phase II research protocol designed to determine the local control with proton beam radiationtherapy in the treatment of unresectable primary hepatocellular carcinoma or intrahepatic cholangiocarcinoma.

Primary Objectives
To demonstrate 2 yr LC of >80% with proton beam irradiation for unresectable liver tumors. This will be benchmarked against 2 yr LC of ~55% for tumors > 3cm in size with radiofrequency ablation.

Secondary Objectives
1. To determine safety and tolerance of this treatment program.
2. To evaluate tumor response, patterns of failure, and survival in patients with hepatocellular
cancer and intrahepatic cholangiocarcinoma, undergoing proton beam irradiation.
3. To evaluate 5 yr overall survival and local control.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/29/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	60

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must have biopsy proven unresectable or locally recurrent hepatocellular cancer or intrahepatic cholangiocarcinoma. Patients with a single lesion must be 12 cm or less in greatest dimension. For patients with two lesions, no lesion may be greater than 10 cm in greatest dimension. For patients with three lesions, no lesion may be greater than 6cm in greatest dimension. Patients may have single or multinodular tumors (up to 3). There must be no evidence of extrahepatic tumor. Portal vein involvement or thrombosis is allowed.

2) 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 CAT scan (CT).

3) Patients may have had prior chemotherapy, targeted biological therapy (ie sorafenib, etc...), surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as >/= 4 weeks from first protocol radiation treatment , (6 weeks for nitrosoureas or mitomycin C) . Patients may not have had prior radiation to the affected area.

4) Patients must be 18 years of age or older.

5) Expected survival must be greater than three months.

6) ECOG performance status </=2.

7) Participants must have normal organ and marrow function as defined below: Absolute neutrophil count (ANC) >/= 1,500/mcL, Platelets >/= 50,000/mcL, total bilirubin </= 4.0 X institutional upper limit of normal, AST (SGOT)/ALT (SGPT) </= 5.0 X institutional upper limit of normal, Creatinine </= 2mg/dl or creatinine clearance >/= 60 mL/min/1.73 m^2 (Calculated per Cockroft & Gault formula) for subjects with creatinine levels above institutional normal.

8) If patient has underlying cirrhosis, only Child-Pugh classification Group A or Group B patients should be included in this study. 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 other labs required for eligibility analysis.

9) The effects of radiation on the developing human fetus are known to be teratogenic. Therefore, male and female patients of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Female patients of child bearing potential must also have a negative serum pregnancy test. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

10) 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, and basal cell or squamous cell carcinoma of the skin.

11) Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1) Women who are pregnant or lactating.

2) Patients with evidence of non-hepatic metastatic disease.

3) Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.

4) Prior liver directed radiation treatment.

5) Patients may have no serious medical illness, which may limit survival to less than 3 months.

6) Patient may have no serious psychiatric illness/social situations which would limit compliance with study requirements.

7) Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (with the exception of anticipated chronic late effects from chemotherapy not expected to be exacerbated by radiation) due to agents administered more than 4 weeks earlier.

8) Patients may not be receiving any other study agents.

9) Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,

10) Individuals with a history of a different malignancy are ineligible except for the following circumstances; 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.

11) Because no dosing or adverse event data are currently available on the use of high dose liver radiation participants <18 years of age are excluded from this study.

Links

Registration Number: NCT00976898
Study Information on Clinical Trials Registry (clinicaltrials.gov)