Radiation Therapy in Treating Patients With Liver Metastases

Metastatic Cancer Clinical Trial

Official title:

A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255814
• Other study ID #: RTOG-0438
• Secondary ID: CDR0000450766
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2005
• Last updated: November 14, 2015
• Start date: November 2005
• Est. completion date: November 2013

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.

Description:

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.

Secondary

• Determine the failure patterns and survival of patients treated with this regimen.

• Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients.

• Determine the local control rate within irradiated fields in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study.

Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks.

Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Histologically confirmed non-lymphoma liver metastases

• New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver

• No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan

• Liver metastases = 8 cm

• Medically unfit for surgery OR lesions are surgically unresectable

• All intrahepatic disease must be encompassed within the study radiation field

• Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting

• At least 1,000 cc of normal liver

• No clinical ascites

• No CNS metastases

PATIENT CHARACTERISTICS:

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,800/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 8 g/dL (transfusion allowed)

Hepatic

• No active hepatitis

• No clinically significant liver failure

• No underlying cirrhosis

Renal

• Not specified

Cardiovascular

• No congestive heart failure requiring hospitalization within the past 6 months

• No unstable angina pectoris requiring hospitalization within the past 6 months

• No transmural myocardial infarction within the past 6 months

Pulmonary

• No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis

• No acute bacterial or fungal infection requiring IV antibiotics

PRIOR CONCURRENT THERAPY:

Chemotherapy

• At least 4 weeks since prior chemotherapy

• No concurrent chemotherapy

• No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy)

Radiotherapy

• No prior radiotherapy to the region of study

• No concurrent intensity-modulated radiotherapy

Surgery

• Prior liver resection or ablative therapy allowed

Other

• No concurrent warfarin or IV heparin

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximally tolerated dose		From start of treatment to 90 days	Yes