Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

NCT ID: NCT00316862

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2014-10-15

Brief Summary

This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan (irinotecan hydrochloride) followed by concurrent cisplatin/irinotecan and radiation therapy.

SECONDARY OBJECTIVES:

I. To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography (PET) scan.

II. To evaluate the toxicity and tolerability of therapy, including surgical morbidity and mortality.

III. To determine the overall survival, disease free survival, and pattern of failure.

OUTLINE:

INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (chemotherapy, chemoradiotherapy, surgery)

INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

irinotecan hydrochloride

Intervention Type: DRUG

Given IV

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo Surgery

radiation therapy

Intervention Type: RADIATION

Undergo radiation

Interventions

cisplatin

Given IV

Intervention Type: DRUG

irinotecan hydrochloride

Given IV

Intervention Type: DRUG

therapeutic conventional surgery

Undergo Surgery

Intervention Type: PROCEDURE

radiation therapy

Undergo radiation

Intervention Type: RADIATION

Other Intervention Names

irradiation, radiotherapy, therapy, radiation

Eligibility Criteria

Inclusion Criteria

• Disease must be clinically limited to the esophagus or gastroesophageal junction; if the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction; adenocarcinomas of the distal esophagus would therefore include tumors of the distal esophagus, or Siewert type I according to the Siewert classification, and tumors of the gastroesophageal junction which involve equally both the distal esophagus and proximal stomach, or Siewert type II; tumor must be surgically resectable

• No TIS (in-situ carcinoma) and tumors determined to be T1N0 following endoscopic ultrasound
• No clinical involvement on endoscopic ultrasound (EUS), computed tomography (CT) scan, or PET scan of supraclavicular or celiac lymph node involvement (stage IVa, T any N any M1a) unless this is proven to be a false positive by an appropriate biopsy
• No patients with cervical esophageal tumors, or gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus
• No patients with tracheoesophageal fistulas
• Patients with evidence of metastatic disease are not eligible; this includes:

• Positive malignant cytology of the pleura, pericardium or peritoneum
• Radiographic evidence of distance organ involvement including lung, liver, bone, or brain
• No prior chemotherapy or radiotherapy is permitted; patients must be at least 4 weeks since major surgery, or must have recovered from the effects of minor surgery (laparoscopy, thoracoscopy)
• No prior malignancies (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted unless diagnosed and/or treated >= 3 years before registration and without evidence of recurrence
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No evidence of recurrent laryngeal nerve or phrenic nerve paralysis
• No known Gilbert's disease
• No clinically significant hearing loss; audiograms should be done in patients in which they are clinically indicated
• No history of active seizure disorder; no ongoing treatment with phenytoin, phenobarbital, or other antiepileptic medication; patients who are receiving valproic acid are eligible
• No New York Heart Association class III or IV heart disease; no angina or myocardial infarction within the last 6 months

• No history of clinically significant ventricular arrhythmia requiring ongoing medication with antiarrhythmics
• Absolute neutrophil count (ANC) >= 1,500/ul
• Platelet count >= 100,000/ul
• Hemoglobin >= 9 gm/dl
• Serum creatinine =< upper limit of normal (ULN)
• Total serum bilirubin =< 1.5 mg/dl
• Forced expiratory volume in 1 second (FEV-1) >= 1.2 liters OR >= 35% of normal as a value that is indexed to body size
• Pulmonary function tests (PFT) >= 1.2 liters OR >= 35% of normal as a value that is indexed to body size

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H. Ilson, MD, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Elkhart General Hospital

Elkhart, Indiana, United States

Howard Community Hospital

Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend

South Bend, Indiana, United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, United States

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, United States

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, United States

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, United States

Lakes Region General Hospital

Laconia, New Hampshire, United States

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, United States

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Mountainview Medical

Berlin Corners, Vermont, United States

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Countries

United States

Other Identifiers

CDR0000468495

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2009-00491

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-80302

Identifier Type: -

Identifier Source: org_study_id