NCT00255814

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

5.8 years

First QC Date

November 18, 2005

Last Update Submit

November 14, 2015

Conditions

Metastatic Cancer

Keywords

liver metastases

Outcome Measures

Primary Outcomes (1)

  • To determine the maximally tolerated dose

    From start of treatment to 90 days

Study Arms (3)

Radiation therapy dose level II: 4.0 Gy/fx

OTHER

Radiation therapy dose level II: 4.0 Gy/fraction

Radiation: radiation therapy

Radiation therapy dose level III: 4.5 Gy/fx

OTHER

Radiation therapy dose level III: 4.5 Gy/fraction

Radiation: radiation therapy

Radiation therapy dose level IV: 5.0 Gy/fx

OTHER

Radiation therapy dose level IV: 5.0 Gy/fraction

Radiation: radiation therapy

Interventions

radiation therapyRADIATION
Radiation therapy dose level II: 4.0 Gy/fxRadiation therapy dose level III: 4.5 Gy/fxRadiation therapy dose level IV: 5.0 Gy/fx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Alan W. Katz, MD

    James P. Wilmot Cancer Center

    PRINCIPAL INVESTIGATOR

  • Laura A. Dawson, MD

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

November 1, 2005

Primary Completion

September 1, 2011

Study Completion

November 1, 2013

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(1)CA(2)