Clinical Research Details
Title:
A Phase II Study of Oligometastatic Stage IV Non-small Cell Lung Cancer (NSCLC) Treated with Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy
Purpose:
The purpose of this study is to assess whether the addition of radiation therapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival in all eligible Stage IV NSCLC patients.
Study Number:
201997071509
Number of Patients:
98
Elgibility:
Entry criteria is as follows:
18 years of age
Histologic or cytologic confirmation of Stage IV NSCLC
Note: Mixed histology allowed if all components consistent with NSCLC. In
addition, patients whose tumors have squamous cell histology feature are eligible.
Previously untreated disease or SD or PR =eight weeks following one previous
regimen of a standard platinum-based chemotherapy given every three – four weeks for a total of two – six cycles.
Ability to provide informed consent.
Life expectancy =12 weeks.
M1 with one – three metastases but not more. Note: Patients with M1 disease that is other intrapulmonary metastases can be treated as long as the lung V20 is =40%
Treatment:
If you have never been treated for your disease, you will have an X-ray or CT scan or MRI to measure your tumor and then you will be given between two and six three – four week cycles of a standard platinum-based chemotherapy regimen chosen by your doctor. This chemotherapy will be given outside of this study. When you are done getting your chemotherapy, you will have an X-ray or CT scan or MRI to measure your tumor. If your disease has not gotten any worse or if it is only slightly worse, you will begin this study (within the first eight weeks after your chemotherapy).
If you have already completed, within the last eight weeks, a standard platinum-based chemotherapy regimen (given as two – six three – four week cycles), you will have an X-ray or CT scan or MRI to measure your tumor. If your disease has not gotten any worse or if it is only slightly worse, you will begin this study.
If you are in Group 1, you will be randomized to receive no radiation therapy for six weeks.
If you are in Group 2, you will be randomized to receive radiation therapy for three – six weeks.
Principal Investigator:
Enrollment Phone:
(708) 327-3229