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Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01215500
Collaborator
(none)
63
Enrollment
1
Location
1
Arm
157.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Radiation: Hypofractionated RT
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
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
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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: 8 Gy/ fraction x 3 fractions = 24 Gy 10 Gy/fraction x 3 fractions = 30 Gy 12 Gy/fraction x 3 fractions = 36 Gy 14 Gy/fraction x 3 fractions = 42 Gy 16 Gy/fraction x 3 fractions = 48 Gy 18 Gy/fraction x 3 fractions = 52 Gy 20 Gy/fraction x 3 fractions = 60 Gy

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicities [30-90 days]

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

  2. maximum tolerated dose of hypofractionated RT [30-90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Steven Chmura, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01215500
Other Study ID Numbers:
  • 13619B
First Posted:
Oct 6, 2010
Last Update Posted:
Sep 12, 2018
Last Verified:
Sep 1, 2018
Keywords provided by University of Chicago
solid tumor cancer
epithelial carcinoma
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Sep 12, 2018