Back to resultsDose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Primary Purpose
Tumor, Cancer, Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated RT
Sponsored by
About this trial
This is an interventional treatment trial for Tumor focused on measuring solid tumor cancer, epithelial carcinoma
Eligibility 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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation therapy
Arm Description
Outcomes
Primary Outcome Measures
Dose-limiting toxicities
The dose limiting toxicities occurring within the initial observation period will be defined.
maximum tolerated dose of hypofractionated RT
Secondary Outcome Measures
Full Information
NCT ID
NCT01215500
First Posted
August 2, 2010
Last Updated
September 10, 2018
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01215500
Brief Title
Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Official Title
A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Cancer, Melanoma, Sarcoma, Carcinoma
Keywords
solid tumor cancer, epithelial carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation therapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated RT
Intervention Description
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
Primary Outcome Measure Information:
Title
Dose-limiting toxicities
Description
The dose limiting toxicities occurring within the initial observation period will be defined.
Time Frame
30-90 days
Title
maximum tolerated dose of hypofractionated RT
Time Frame
30-90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Chmura, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
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