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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.
Study NCT00033657   Information provided by National Cancer Institute (NCI)
First Received: April 9, 2002   Last Updated: February 6, 2009   History of Changes

April 9, 2002
February 6, 2009
May 2002
 
 
 
Complete list of historical versions of study NCT00033657 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
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

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.

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.

Phase II
Interventional
Treatment, Randomized, Active Control
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: cisplatin
  • Drug: irinotecan hydrochloride
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033657
 
CDR0000069309, ECOG-1201
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Larry Kleinberg, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP