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A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer



- Determine the pathologic complete response rate in patients with surgically resectable
esophageal cancer treated with neoadjuvant induction chemotherapy comprising cisplatin
and irinotecan hydrochloride (CI) followed by chemoradiotherapy comprising CI and


- Evaluate potential response or progression of disease during induction chemotherapy
with positron emission tomography (PET) scan.

- Evaluate the toxicity and tolerability of this regimen, including surgical morbidity
and mortality, in these patients.

- Determine the overall survival, disease-free survival, and pattern of failure in
patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Induction chemotherapy: Patients receive irinotecan hydrochloride IV over 30-90 minutes
and cisplatin IV over 30 minutes on days 1 and 8 in courses 1 and 2. Treatment repeats
every 21 days for up to 4 courses in the absence of disease progression or unacceptable

- Chemoradiotherapy: Beginning 2 weeks after completion of induction chemotherapy,
patients receive irinotecan hydrochloride and ciplatin as above on days 1 and 8 in
courses 3 and 4 and undergo radiotherapy daily in course 3.Treatment repeats every 21
days for up to 4 courses in the absence of disease progression or unacceptable

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

Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging at
baseline, 15-19 days after the start of induction chemotherapy, and within 7 days before
beginning chemoradiotherapy.

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

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed carcinoma of the esophagus or
gastroesophageal junction of 1 of the following subtypes:

- Squamous cell carcinoma (closed to accrual as of 04/19/10)

- Adenocarcinoma

- Poorly differentiated carcinoma

- Carcinoma not otherwise specified

- Meets 1 of the following stage criteria:

- T2-4, N0-1, M0 disease by endoscopic ultrasound (EUS)

- T1 tumors allowed if they are T1, N1, M0

- Regional thoracic lymph node involvement (N1) is allowed

- No in situ carcinoma

- No clinical involvement of supraclavicular or celiac lymph nodes by EUS, CT
scan, or PET scan unless proven to be false positive by biopsy

- Meets the following criteria regarding extent of disease:

- Disease must be clinically limited to the esophagus or gastroesophageal

- If the tumor extends below the gastroesophageal junction into the proximal
stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal
junction* NOTE: *Adenocarcinomas of the distal esophagus include tumors of the
distal esophagus, or Siewert type I; 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 cervical esophageal tumors

- No gastric cancers with minor involvement of the gastroesophageal junction or distal

- No tracheoesophageal fistulas

- No evidence of metastatic disease, including either of the following:

- Positive malignant cytology of the pleura, pericardium, or peritoneum

- Radiographic evidence of distant organ involvement, including lung, liver, bone,
or brain


- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 9 g/dL

- Creatinine normal

- Bilirubin ≤ 1.5 mg/dL

- FEV_1 and pulmonary function test ≥ 1.2 liters OR ≥ 35% of normal

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of clinically significant ventricular arrhythmia requiring ongoing
medication with antiarrhythmic drugs

- No myocardial infarction within the past 6 months

- No angina

- No New York Heart Association class III or IV heart disease

- No history of active seizure disorder

- No clinically significant hearing loss

- No known Gilbert's disease.

- No evidence of recurrent laryngeal nerve or phrenic nerve paralysis

- No prior malignancies except basal cell or squamous cell skin cancer, carcinoma in
situ of the cervix, superficial transitional cell bladder carcinoma, or other cancer
for which the patient has been disease free for at least 3 years


- At least 4 weeks since prior major surgery

- Recovered from the effects of minor surgery (including laparoscopy or thoracoscopy)

- No prior chemotherapy

- No prior radiotherapy

- No ongoing treatment with phenytoin, phenobarbital, or other antiepileptic medication

- Valproic acid allowed

- No concurrent palliative radiotherapy

- No concurrent intensity-modulated radiotherapy

- No concurrent treatment with hormones or other chemotherapeutic agents except for the

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- Dexamethasone as an antiemetic prior to cisplatin therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate after surgery

Safety Issue:


Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough, Maine  04074
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Mountainview Medical Berlin, Vermont  05602
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Elliot Regional Cancer Center at Elliot Hospital Manchester, New Hampshire  03103
Lakes Region General Hospital Laconia, New Hampshire  03246
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106