Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT00400114
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
  • Cisplatin — DRUG
    Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
  • Radiation — PROCEDURE
    Radiation 50 Gy (weeks 4-9)
  • Surgery — PROCEDURE
    Esophagectomy
  • sunitinib (Sutent) — DRUG
    sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.

Study Details

The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.

Key Dates

Start date
Sep 25, 2006
Status verified
May 2017
Primary completion
Sep 19, 2016
Completion
Sep 19, 2016

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sunitinib

Primary Outcome Measure

To determine the feasibility and efficacy of adjuvant Sutent therapy after concurrent neoadjuvant therapy with Irinotecan, Cisplatin, external beam conformal radiotherapy plus surgery for potentially resectable esophageal cancer. [ Time Frame: 5 yrs ]

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