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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033657
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: cisplatin
Drug: irinotecan hydrochloride
Drug: paclitaxel
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Stomach Cancer   

ChemIDplus related topics:   Cisplatin    Irinotecan    Irinotecan hydrochloride    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   May 2002

Detailed Description:

OBJECTIVES:

  • 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.
  • Compare the survival outcome in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients.
  • Compare time to progression or recurrence in patients treated with these regimens.

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.

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033657

Show 23 study locations  Show 23 Study Locations

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Larry Kleinberg, MD     Sidney Kimmel Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 

Study ID Numbers:   CDR0000069309, ECOG-1201
First Received:   April 9, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00033657
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I gastric cancer  
stage II gastric cancer  
stage III gastric cancer  
stage IV gastric cancer  
stage I esophageal cancer  
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Stomach cancer
Camptothecin
Carcinoma
Digestive System Diseases
Stomach Diseases
Cisplatin
Paclitaxel
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 10, 2008




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