Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
This study is for patients who have esophageal cancer that is limited to the local area around the esophagus.
The purpose of this study is to learn if we can improve the outcomes for patients with esophageal cancer by using PET/CT scans to determine whether or not a particular chemotherapy regimen is showing any effect on the tumor. We are trying to learn if PET/CT response can be used as a way to better direct therapy for this type of cancer.
PET scans show the activity of cells and can help your doctor to measure how active tumor cells are. Previous studies among patients with esophageal cancer have shown that comparing PET/CT scans prior to starting chemotherapy and after receiving several weeks of therapy can predict those who are poor responders to chemotherapy and those who have a better response to chemotherapy. We are using two different chemotherapy regimens, which are FDA approved for this type of cancer, as induction chemotherapy, meaning the chemotherapy is given first, prior to radiation therapy and surgery. The two chemotherapy regimens have been studied in esophageal cancer and have been found to have similar effects on tumors. The two chemotherapy regimens are FOLFOX6 and carboplatin/ paclitaxel.
This is a Phase II randomized trial. Phase II trials are studies that evaluate the efficacy of a treatment approach (how well the treatment works). This study also includes a randomization which means that subjects will be randomly assigned to one of the two treatment groups.
A Pilot Study Of Molecular Profile-Directed Chemotherapy For Metastatic HER2(-) Esophagogastric Adenocarcinoma (mEGA).
Subjects are being asked to participate in this study because they have esophagogastric adenocarcinoma (cancer affecting the esophagus and stomach).
The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests (molecular studies) will be performed on a sample of tumor; based on the results of these tests, the subject will be assigned to one of seven "doublet" chemotherapy treatments. "Doublet" is the name given to the combination of two standard chemotherapies. Each of these combinations has been safely used in patients with esophagogastric adenocarcinoma or other types of cancer. The purpose of this study is to determine the ability to personalize therapy in this manner, and to determine how many patients a larger study would need. A second purpose is not to determine if one doublet is better than another. Rather, this second purpose is to show that for all patients enrolled in this protocol who have been assigned a doublet based on their tumor's molecular analysis (molecular tailoring), treatment response will be better than would be expected compared to patients who have been treated in the past with no molecular tailoring.