Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

The University of Chicago

Status and phase

Completed

Phase 1

Conditions

Sarcoma

Melanoma

Carcinoma

Cancer

Tumor

Treatments

Radiation: Hypofractionated RT

Study type

Interventional

Funder types

Other

Identifiers

NCT01215500

13619B

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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