Gastrointestinal Cancer 3475-181

April 26, 2017

Sponsor: Merck Sharp & Dohme Corp.

Number: 3475-181

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III: the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) that studies radiation therapy alone to see how well it works compared with radiation therapy and Cetuximab. This study focuses on treating patients who have undergone surgery for head and neck cancer that has spread to nearby tissues or organs. Radiation therapy uses high-energy x-rays to kill tumor cells. Using a 3-dimensional (3-D) image of the tumor to help focus the radiation directly onto the tumor, and giving the radiation in higher doses over a shorter period of time, may kill more tumor cells and cause fewer side effects. Monoclonal antibodies, such as Cetuximab, may block tumor growth by targeting certain cells. It is not yet known whether radiation therapy is more effective when given alone or together with Cetuximab in treating patients with head and neck cancer that has been removed by surgery.

Who’s eligible:

  • The patient must have histologically (tissue microscopically examined)- or cytologically (fluid cells microscopically examined)-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma . Siewert type I is adenocarcinoma of distal part of the esophagus (centre located within between 1-5cm above the anatomic   esophago-gastric junction) of the EGJ (Esophagogastric junction).
  • The patient can have either metastatic disease or locally advanced, unresectable disease.
  • Life expectancy of the patient must be greater than 3 months. There must be measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST-a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment).
  • There must be documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy.
  • This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office