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Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01215500
First Posted: October 6, 2010
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  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 Phase
Tumor Cancer Melanoma Sarcoma Carcinoma Radiation: Hypofractionated RT Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by University of Chicago:

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

  • maximum tolerated dose of hypofractionated RT [ Time Frame: 30-90 days ]

Enrollment: 63
Study Start Date: January 2005
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation therapy 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215500


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Steven Chmura, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01215500     History of Changes
Other Study ID Numbers: 13619B
First Submitted: August 2, 2010
First Posted: October 6, 2010
Last Update Posted: July 6, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes