Conditions: Esophageal Cancer
Keywords: Operable Based on CHFR Methylation Status Diagnostic Biopsies
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy arm 2: Cisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy arm 3: Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy

Interventions: intervention 1: Paclitaxel intervention 2: Cisplatin intervention 3: Oxaliplatin intervention 4: 5-Fluorouracil intervention 5: Radiotherapy intervention 6: Esophagectomy
Intervention descriptions: intervention 1: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. intervention 2: 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. intervention 3: Oxaliplatin 85 mg/m2 days 1, 15, 29. intervention 4: 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. intervention 5: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. intervention 6: 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).

Protocol document: