Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	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 Radiation: radiation therapy	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer Surgery

Drug Information available for: Cisplatin Paclitaxel Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

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

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Larry Kleinberg, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

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

Publications:

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
Study First Received:	April 9, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00033657 History of Changes
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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Irinotecan
Physiological Effects of Drugs
Neoplasms by Site
Stomach Diseases
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Digestive System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors

Antimitotic Agents
Camptothecin
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Head and Neck Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009