Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatments cisplatin, irinotecan hydrochloride, therapeutic conventional surgery, radiation therapy
Phase phase 2
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date February 2006
End date December 2012
Trial size 90 participants
Trial identifier NCT00316862, CALGB-80302, CDR0000468495, NCI-2009-00491, U10CA180821

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cisplatin
Given IV
irinotecan hydrochloride
Given IV
therapeutic conventional surgery
Undergo Surgery
radiation therapy irradiation, radiotherapy, therapy, radiation
Undergo radiation

Primary Outcomes

Measure
Proportion of patients with adenocarcinoma achieving a pathologic complete response (CR) after surgery
time frame: After surgery

Secondary Outcomes

Measure
Utility of early PET imaging in predicting response to treatment
time frame: Up to 55 days
Disease-free survival
time frame: Up to 5 years
Overall survival
time frame: Up to 5 years
Patterns of failure
time frame: Up to 5 years
Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: Up to 5 years
Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, graded using the NCI CTCAE version 4.0
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

- Histologically or cytologically confirmed adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of the esophagus or gastroesophageal junction; biopsy or cytology of the primary tumor, or of involved regional lymph nodes, is acceptable - Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic ultrasound; T1 tumors are eligible if they are T1, N1, M0; regional thoracic lymph node involvement (N1) is permitted - 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 Inclusion Criteria: - 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

Additional Information

Official title A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.