Trial | NCT00139633  Report issue

Title

Selective Dose Escalation for Esophageal Cancer
Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    25
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.
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.
Study Started
Jul 31
2000
Study Completion
Jun 30
2005
Last Update
Aug 31
2005
Estimate

Drug carboplatin, 5FU, Taxol and radiation

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

distant metastases
No Results Posted