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Esophageal Neoplasms

Gastrointestinal Neoplasms

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Esophageal Cancer

Antineoplastic Agents

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Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Oxaliplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy

Cisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy

Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy

Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.

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.

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.

5-Fluorouracil

Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

Radiotherapy

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).

Esophagectomy

Ronan Kelly, M.D.

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.

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.

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

CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.

Overall survival with given treatment strategy.

To determine time to disease progression with this treatment strategy.

To determine the agreement between tumor CHFR methylation and detection in plasma.

National Cancer Institute (NCI)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy

Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.

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.

Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

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).

Arm A

Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy

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.

Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.

5-Fu: Oxaliplatin \& 5-fu:

* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation

Cisplatin/5-fluorouracil:

* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.

Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

Arm B

Arm C

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Ronan Kelly, MD

Pathological Complete Response

Cisplatin or Oxaliplatin, 5-Fluorouracil along , Radiotherapy and followed by Esophagectomy

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 hs days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.

Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.

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.

Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the opera

Cisplatin with 5-Fluorouracil with Radiotherapy and followed by Esophagectomy

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.

  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.

Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

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 star

Survival

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.

Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.

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.

Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the opera

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.

  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.

Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.

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 star

Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.

Spots Global Cancer Trial Database for diagnostic biopsies