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Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steven Chmura, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT01215500
First received: August 2, 2010
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.

The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.


Condition Intervention
Tumor
Cancer
Melanoma
Sarcoma
Carcinoma
 Radiation: Hypofractionated RT

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Dose-limiting toxicities [ Time Frame: 30-90 days ] [ Designated as safety issue: Yes ]
    The dose limiting toxicities occurring within the initial observation period will be defined.

  • maximum tolerated dose of hypofractionated RT [ Time Frame: 30-90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: January 2005
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Hypofractionated RT

    RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy:

    For all sites the dose levels are as follows:

    1. 8 Gy/ fraction x 3 fractions = 24 Gy
    2. 10 Gy/fraction x 3 fractions = 30 Gy
    3. 12 Gy/fraction x 3 fractions = 36 Gy
    4. 14 Gy/fraction x 3 fractions = 42 Gy
    5. 16 Gy/fraction x 3 fractions = 48 Gy
    6. 18 Gy/fraction x 3 fractions = 52 Gy
    7. 20 Gy/fraction x 3 fractions = 60 Gy
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 required
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215500

Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Steven Chmura, MD University of Chicago
  More Information

No publications provided

Responsible Party: Steven Chmura, MD, Asst Prof Radiation & Cellular Oncology, University of Chicago
ClinicalTrials.gov Identifier: NCT01215500     History of Changes
Other Study ID Numbers: 13619B
Study First Received: August 2, 2010
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
solid tumor cancer
epithelial carcinoma

Additional relevant MeSH terms:
Carcinoma
Melanoma
Neoplasm Metastasis
Sarcoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on May 19, 2013