This trial is active, not recruiting.

Conditions tumor, cancer, melanoma, sarcoma, carcinoma
Treatment hypofractionated rt
Phase phase 1
Sponsor University of Chicago
Start date January 2005
End date June 2016
Trial size 63 participants
Trial identifier NCT01215500, 13619B


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Primary Outcomes

Dose-limiting toxicities
time frame: 30-90 days
maximum tolerated dose of hypofractionated RT
time frame: 30-90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Principal investigator Steven Chmura, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Chicago.