Clinical trial NCT00590031: Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Official title: Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Carcinoma
Keywords: Esophageal Carcinoma
Cisplatin
Irinotecan
Radiation Therapy
02-045
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be able to sign the informed consent document.

Exclusion Criteria:

* Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
* Cervical esophageal tumors,
* Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
* Prior chemotherapy or radiation.
* Patients with evidence of metastatic disease are not eligible. This includes:
* Positive malignant cytology of the pleura, pericardium or peritoneum.
* Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
* Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
* Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
* New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
* Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
* Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
* History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
* Patients with known Gilbert's Disease.
* Clinically significant hearing loss.
* Serum calcium_\>12 mg/dl.
* Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
* Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
* Patients with any other concurrent medical or psychiatric condition or disease, which, in the investigator's judgment, would make the patient inappropriate for entry into this study.

Primary outcomes:
measure: Pathologic Complete Response
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Ilson, MD
role: PRINCIPAL_INVESTIGATOR
References: