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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the maximally tolerated dose

Outcome Time Frame:

From start of treatment to 90 days

Safety Issue:

Yes

Principal Investigator

Alan W. Katz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG-0438

NCT ID:

NCT00255814

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • liver metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642