Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Esophageal Carcinoma Clinical Trial

Official title:

Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590031
• Other study ID #: 02-045
• Secondary ID: IND 65889
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: December 18, 2015
• Start date: November 2002
• Est. completion date: December 2009

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Drug:
• Cisplatin
pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
• Irinotecan
Irinotecan will be given 65 mg/m2

Radiation:
• External Beam Radiation Therapy
will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response	Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.	2 years	No
Secondary	Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality		2 years	Yes

External Links

•   Memorial Sloan-Kettering Cancer Center