Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal
      antibodies, such as cetuximab, can block tumor growth in different ways. Some block the
      ability of tumor cells to grow and spread. Others find tumor cells and help kill them or
      carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by
      blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin
      together with radiation therapy is more effective with or without cetuximab in treating
      esophageal cancer.

      PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and
      cisplatin together with radiation therapy works with or without cetuximab in treating
      patients with locally advanced esophageal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel,
           cisplatin, and radiotherapy improves overall survival compared with paclitaxel,
           cisplatin, and radiotherapy alone in patients with esophageal cancer treated without
           surgery.

      Secondary

        -  To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy
           improves local control by increasing the clinical complete response and decreasing local
           recurrence in these patients.

        -  To evaluate adverse events in these patients.

        -  To evaluate endoscopic complete response rates in these patients.

        -  To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy
           improves the Esophageal Cancer Subscale (ECS) score of the Functional Assessment of
           Cancer Therapy - Esophagus (FACT-E) quality of life tool.

        -  To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the
           primary endpoint supports the primary hypothesis.

      OUTLINE: This is a multicenter study. Patients are stratified according to histology
      (adenocarcinoma vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of
      celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.
    

Intervention name(s): cetuximab; cisplatin; paclitaxel; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.; Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.; Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.; 1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
Intervention MeSH terms: Paclitaxel; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stage IIA esophageal cancer; stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; stage IV esophageal cancer; squamous cell carcinoma of the esophagus