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Selective Dose Escalation for Esophageal Cancer

Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00139633
Enrollment
25
Registered
2005-08-31
Start date
2000-07-31
Completion date
2005-06-30
Last updated
2005-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

esophageal cancer, chemotherapy, radiation

Brief summary

This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.

Detailed description

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.

Interventions

DRUGcarboplatin, 5FU, Taxol and radiation

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
MedImmune LLC
CollaboratorINDUSTRY
The Oregon Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* distant metastases

Design outcomes

Primary

MeasureTime frame
survival at 4 years
local control at 4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026