Radiation Therapy in Treating Patients With Liver Metastases

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 1

Conditions: Metastatic Cancer

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00255814

CDR0000450766

RTOG-0438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Radiation therapy dose level II: 4.0 Gy/fx

Other group

Description:

Radiation therapy dose level II: 4.0 Gy/fraction

Treatment:

Radiation: radiation therapy

Radiation therapy dose level III: 4.5 Gy/fx

Other group

Description:

Radiation therapy dose level III: 4.5 Gy/fraction

Treatment:

Radiation: radiation therapy

Radiation therapy dose level IV: 5.0 Gy/fx

Other group

Description:

Radiation therapy dose level IV: 5.0 Gy/fraction

Treatment:

Radiation: radiation therapy