A Phase II Study of PET Scan-Directed Combined Modality Therapy for Esophageal Cancer

Protocol
12-011
Full Title
Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer (CALGB 80803)
Phase
II
Purpose

Chemotherapy, radiation therapy, and surgery are all used to treat esophageal cancer, but doctors are trying to determine the most effective way to give them. Not all patients respond the same way to therapy. In this study, investigators are using positron emission tomography (PET) scanning, combined with computed tomography (CT) scanning, to monitor how patients with stage II or III esophageal cancer respond to chemotherapy and to determine the most appropriate therapy they should continue having based on the scan results.

Patients will be randomly assigned to start treatment with one of two chemotherapy regimens: a combination of drugs collectively called FOLFOX6, or two drugs called carboplatin and paclitaxel. Patients will then receive radiation therapy followed by surgery.

After completion of two to three cycles of chemotherapy (depending on which regimen they start on), patients will have a PET/CT scan. If the scan results suggest a good response to treatment, they will continue receiving the same chemotherapy. If the tumor response is not sufficient, doctors will switch patients to the other treatment (FOLXFOX6 to carboplatin/paclitaxel, or vice versa) during the radiation therapy period. Investigators will determine if using PET/CT scanning to guide treatment can improve patient outcomes.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II or III cancer of the esophagus or gastroesophageal junction.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. David Ilson at 646-888-4183.

Disease(s)
Upper Gastrointestinal: Esophageal Cancer
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