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Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer


we prospectively enrolled patients with T1–4, N0–1, M0–1a esophageal carcinoma to receive
paclitaxel 45 mg/m2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1, 8,
15, 22, 29 and 36. 5-FU 225mg/m2 was delivered as a continuous infusion on days 1–38. RT
was given 1.8Gy 5 days/wk for 5.5 wks (50.4Gy in 28 fx). After 6–8 weeks, patients
underwent repeat staging with computed tomography (CT) scan, endoscopic ultrasound (EUS),
and biopsy. Patients with a positive biopsy, or less than PR by CT and EUS, received a
boost of 9 Gy with the same concurrent chemotherapy. Patients were followed every 4 months
with CT/EUS first year, every 6 months thereafter.


Inclusion Criteria:



- T1–4, N0–1, M0–1a esophageal carcinoma

Exclusion Criteria:

- distant metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

survival at 4 years

Principal Investigator

Steven K Seung, MDPhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Oregon Clinic

Authority:

United States: Institutional Review Board

Study ID:

ETH097-02D

NCT ID:

NCT00139633

Start Date:

July 2000

Completion Date:

June 2005

Related Keywords:

  • Esophageal Cancer
  • esophageal cancer, chemotherapy, radiation
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

The Oregon ClinicPortland, Oregon  97213