Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-1201 E1201, NCT00033657

Objectives

1. Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.
2. Compare the survival outcome in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients.
5. Compare time to progression or recurrence in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction
  • Stage T2-3, N0, M0

    OR

  • Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)



• Tumor must not extend more than 2 cm into the cardia



• Tumor must be considered surgically resectable (T1-3, but not T4)

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent filgrastim (G-CSF) during study radiotherapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics
• No prior surgery

Other:

• Endoscopy with biopsy and dilation allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,000/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine clearance at least 60 mL/min

Other:

• No other concurrent illness that would preclude study therapy or surgical resection
• Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 46-94 patients (23-47 per treatment arm) will be accrued for this study within 1.5-3 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and stage of disease (T2-3, N0, M0 vs T1-3, N0-1, M0 or M1A). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses.



• Arm II: Patients receive neoadjuvant radiotherapy as in arm I concurrently with neoadjuvant chemotherapy comprising paclitaxel IV over 1 hour followed by cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then undergo surgical resection as in arm I. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Kleinberg L, Powell ME, Forastiere AA, et al.: Survival outcome of E1201: An Eastern Cooperative Oncology Group (ECOG) randomized phase II trial of neoadjuvant preoperative paclitaxel/cisplatin/radiotherapy (RT) or irinotecan/cisplatin/RT in endoscopy with ultrasound (EUS) staged esophageal adenocarcinoma. [Abstract] J Clin Oncol 26 (Suppl15): A-4532, 2008.

Kleinberg LR, Eapen S, Hamilton S, et al.: E1201: an Eastern Cooperative Oncology Group (ECOG) randomized phase II trial to measure response rate and toxicity of preoperative combined modality paclitaxel/cisplatin/RT or irinotecan/cisplatin/RT in adenocarcinoma of the esophagus. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-143, S80, 2006.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Larry Kleinberg, MD, Protocol chair		Ph: 410-614-2497 Email: kleinla@jhmi.edu

Registry Information
Official Title		A Randomized Phase II Study in Operable Adenocarcinoma of the Esophagus to Measure Response Rate and Toxicity of Preoperative Combined Modality Paclitaxel/Cisplatin/RT or Irinotecan/Cisplatin/RT Followed by Postoperative Chemotherapy with the Same Agents
Trial Start Date		2002-05-21
Registered in ClinicalTrials.gov		NCT00033657
Date Submitted to PDQ		2002-02-25
Information Last Verified		2005-12-09
NCI Grant/Contract Number		U10-CA21115

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