Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation

NCT00178243 | Completed Phase 1

• 1 other identifier: URCC 2298
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with liver cancer will be treated with high dose conformal radiation therapy. This type of radiation uses new techniques which aim the radiation to the sites of disease allowing the tumor to receive a high dose and the surrounding normal liver tissue to receive a low enough dose that the normal tissue should remain free from injury. The purpose of the study is to determine if the conformal radiation therapy is safe, tolerable and effective in treating liver cancer and to determine the side effects caused by this treatment. A second objective is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to this treatment.

Conditions

Liver Neoplasms; Neoplasm Metastasis

Interventions

3D Conformal Radiation Therapy and Radiosurgery PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Patients must have new hepatic lesions suggestive of metastasis, or otherwise biopsy proven disease if there is no previously negative scan.
• Patients with chemotherapy responsive or resistant disease are acceptable. Primary hepatobiliary tumors are also acceptable. In each case, the patient must be deemed unresectable by a hepatic surgeon.
• Patients with multiple hepatic lesions may be included if they meet the volumetric criteria for dose specification. Likewise, patients with metastases to organs other than the liver, or patients with residual primary disease may be included if it is judged that longevity will be determined by the hepatic disease.
• KPS ≥70
• Age ≥ 18 years
• Bilirubin \<2.0 mg/dl, AST \< 2.5 x normal, ALT \< 2.5 x normal, Platelets \> 80,000/mm3
• Chemotherapy treatment before or after radiation will be allowed
• Informed consent must be obtained., Patient must be judged unresectable by a hepatic surgeon, or must have refused surgery
• Patient must be able to tolerate radiation treatment as judged by the Principal Investigator or co-PI.
• Previous Liver resection is allowed
• Active disease outside the liver is allowed.
• Liver lesion should be visible on CT or MRI.

You may not qualify if:

• No active hepatitis or radiographic evidence of diffuse macro-nodular cirrhosis. Patients with lesser degrees of cirrhosis, not associated with portal hypertension or hepatic failure, are eligible but radiation schedule and total dose will be appropriately modified.
• Women who are pregnant

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Interventions

Radiotherapy, Conformal; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul Okunieff, MD

  Universtiy of Rochester, Dept of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Last Updated: September 8, 2006

Record last verified: 2006-09

Locations

US (1)