A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma (mEGA)

NCT02358863 NA TERMINATED Results posted

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 will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.

Details

Lead sponsor	Georgetown University
Phase	NA
Status	TERMINATED
Enrolment	13
Start date	2015-02
Completion	2016-11

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

• Modified FOLFOX6
• Docetaxel/Capecitabine
• Cisplatin/Irinotecan
• Cisplatin/Docetaxel
• IRI/EPI
• EPI/Docetaxel
• Irinotecan/Docetaxel
• Docetaxel

Primary outcomes

• The Number of Patients With Tumor Size Reduction (Objective Response Rate) — 1 year
  Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Countries

United States