NCT01372202

CHFR Methylation Status Esophageal Cancer Study

A Phase 2 Study of Paclitaxel With Cisplatin Versus Fluoropyrimidine With a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.

Detailed description

Primary Objectives • To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens. Secondary Objectives * To determine the survival outcome with this treatment strategy. * To determine time to disease progression with this treatment strategy. * To determine the agreement between tumor CHFR methylation and detection in plasma.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
DRUG	Cisplatin	Paclitaxel and cisplatin: * Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. * Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32. * Cisplatin 75 mg/m² days 1, 29.
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m2 days 1, 15, 29.
DRUG	5-Fluorouracil	Oxaliplatin and 5-fluorouracil: * Oxaliplatin 85 mg/m2 days 1, 15, 29. * 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days) Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32. * Cisplatin 75 mg/m² days 1, 29.
RADIATION	Radiotherapy	Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
PROCEDURE	Esophagectomy	The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-06-01
• Completion: 2014-10-01
• First posted: 2011-06-13
• Last updated: 2019-01-25
• Results posted: 2017-08-30

Locations

1 site across 1 country: United States