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A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

18 Years
Open (Enrolling)
Tumor, Cancer, Melanoma, Sarcoma, Carcinoma

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Trial Information

A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of cancer (including epithelial
carcinoma, sarcoma, and melanoma)

- Age 18 years and older

- Life expectancy of > 3 months

- Patients with AJCC (6th edition, 2002) stage IV cancer with distant metastases and
without pleural or pericardial effusion at diagnosis and before start of study

- Patients with 1-5 sites of maximum tumor dimension (for each individual site) of ≤ 10
cm or < 500 cc volume and amenable to radiation therapy as seen on standard imaging

- Unidimensionally measurable disease (based on RECIST) is desirable but not strictly

- Brain metastases must have been treated prior to enrollment on study, preferably with
stereotactic radiosurgery

- ECOG performance status ≤ 2 or Karnofsky Performance Status ≥ 60%

- No prior radiation therapy to currently involved tumor sites

- Room air saturation > 90%

- Hemoglobin > 9.0 g/dl

- ANC >=1,500/microliter

- Platelets >=100,000/microliter

- Total bilirubin within institutional limits

- Albumin > 2.9 g/dl

- Alkaline phosphatase < 2.5x upper limit of normal

- AST and ALT < 2.5 x upper limit of normal

- Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

- Uncontrolled intercurrent illness

- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
history of clinically significant CHF are excluded. Exclusion of patients with
active coronary heart disease will be at the discretion of the attending physician

- Patients with significant atelectasis such that CT definition of gross tumor volume
is difficult to determine

- Pregnancy or breast feeding

- Patients must have no uncontrolled active infection other than that not curable with
treatment of their cancer.

- Patients may not be receiving any other investigational drugs during RT

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities

Outcome Description:

The dose limiting toxicities occurring within the initial observation period will be defined.

Outcome Time Frame:

30-90 days

Safety Issue:


Principal Investigator

Steven Chmura, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

April 2013

Related Keywords:

  • Tumor
  • Cancer
  • Melanoma
  • Sarcoma
  • Carcinoma
  • solid tumor cancer
  • epithelial carcinoma
  • Carcinoma
  • Melanoma
  • Neoplasm Metastasis
  • Sarcoma