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Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

NCT01215500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-09-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Steven Chmura, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215500 on ClinicalTrials.gov