Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00137852
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Given weekly on weeks 1, 2, 4 and 5 during radiation therapy.
  • Irinotecan — DRUG
    Given weekly on weeks 1, 2, 4 and 5 during radiation therapy
  • Celecoxib — DRUG
    Given twice daily 3 days prior to radiation and up until one week prior to surgery. It will then be started again once the participant is released from the hospital following surgery for 26 weeks.
  • Radiation Therapy — PROCEDURE
    5 days a week for 5-6 weeks
  • Esophagectomy — PROCEDURE
    Within 4-8 weeks of chemoradiation therapy

Study Details

This is a study for patients with resectable, locally advanced esophageal cancer. There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan (CPT-11) may work well with radiation therapy to kill cancer cells. The primary goal is to develop a well-tolerated cancer treatment that has an acceptable response rate.

Key Dates

Start date
Jan 31, 2002
Status verified
Sep 2017
Primary completion
Aug 31, 2004
Completion
Sep 30, 2017

Study Design

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

Arms

  • Experimental: Cisplatin/CPT-11/Celecoxib/XRT/Surgery
    Cisplatin, CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer

Primary Outcome Measure

Response rate of combination of chemotherapy, radiation therapy and surgery in resectable esophageal carcinoma

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

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