Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

NCT00607828 | Completed Results DMC

• 2 other identifiers: 0337-07-FBP30CA036727
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I trial studying the side effects and best dose of stereotactic radiation therapy (SRT) in treating patients with advanced liver cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• The Safety of Hypofractionated Stereotactic Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

  Toxicity as assessed by NCI CTCAE v3.0 (Adverse Events). Due to delayed toxicities attributable to radiotherapy, all toxicities observed within 1 month after SRT will be scored. Dose limiting toxicity (DLT) is defined as any of following toxicities, that is possibly, probably or definitely related to Stereotactic Radiation Therapy (SRT) occurring within 1 month from the start of treatment: 1. grade 4 or 5 hepatic 2. grade 4 or 5 gastrointestinal 3. grade 4 or 5 thrombocytopenia 4. grade 4 hepatic liver enzyme elevations persisting for ≥ 5 days 5. any adverse event requiring interruption of therapy by ≥ 2 weeks (14 calendar days).

  Up to 1 month after Stereotactic Radiation Therapy (SRT) treatment

Secondary Outcomes (1)

• Response at 1-month Post SRT

  Measured from first day of SRT to 1-month post SRT.

Study Arms (1)

Hypofractionated stereotactic radiotherapy (SRT)

EXPERIMENTAL

All patients who have had successful implantation of a liver marker will undergo a 4D CT scan for planning SRT. Following transfer to the treatment planning system, the CT scan may be correlated by imaging fusion with MRI for contouring integrated tumor volume (ITV). The planning target volume (PTV) will be defined as ITV plus individualized margins which are determined by a 4D CT scan. Novalis with 6MV photons will be used for imaging guided SRT. Cohorts of 3-6 patients will receive SRT at daily doses of 8, 10, 12, 14 Gy within 2 weeks. The starting daily dose level will be 10 Gy. The marker will be localized by orthogonal X-ray to ensure reproducibility. A continuous respiratory gating will be accomplished with ExacTrac Adaptive Gating system if the required planning target margin is larger than 1 cm based on the 4D CT data.

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

Undergo radiotherapy

Hypofractionated stereotactic radiotherapy (SRT)

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)
• Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm
• Child-Pugh class A-B cirrhotic status
• Karnofsky performance status 60-100%
• Life expectancy ≥ 12 weeks
• White blood cell count (WBC) ≥ 2,000/μL
• Platelet count ≥ 60,000/mm³
• Hemoglobin ≥ 8.5 g/dLINR ≤ 2.3
• More than 6 months since prior myocardial infarction
• Prior systemic chemotherapy allowed
• At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
• Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in Prothrombin time (PT/INR) and partial thromboplastin time (PTT) exists

You may not qualify if:

• No known central nervous system (CNS) tumors, including metastatic brain disease
• No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated \> 3 years prior to study entry
• No renal failure requiring hemodialysis or peritoneal dialysis
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection \> grade 2
• New York Heart Association (NYHA) class II-IV congestive heart failure
• Active coronary artery disease
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
• Uncontrolled hypertension
• Condition that could jeopardize the safety of the patient or study compliance
• No history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
• No condition that would prevent the patient from undergoing marker implantation
• Not pregnant or nursing/negative pregnancy test
• No substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results
• No prior radiotherapy to the liver

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Chi Lin
• Organization: University of Nebraska Medical Center

clin@unmc.edu

402-552-3844

Study Officials

• Chi Lin, MD, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 6, 2008
• Study Start: November 16, 2007
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Locations

US (1)