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

NCT ID: NCT00590031

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Esophageal Carcinoma

Study Design

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

Study Groups

1

External Beam Radiation Therapy, Cisplatin, Irinotecan

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12

Irinotecan

Intervention Type: DRUG

Irinotecan will be given 65 mg/m2

External Beam Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

Cisplatin

pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12

Intervention Type: DRUG

Irinotecan

Irinotecan will be given 65 mg/m2

Intervention Type: DRUG

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.

Intervention Type: RADIATION

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.

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

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ilson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

IND 65889

Identifier Type: -

Identifier Source: secondary_id

02-045

Identifier Type: -

Identifier Source: org_study_id