Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer
4 other identifiers
interventional
82
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2006
Longer than P75 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 19, 2006
CompletedFirst Posted
Study publicly available on registry
April 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2014
CompletedResults Posted
Study results publicly available
March 15, 2017
CompletedMay 8, 2018
April 1, 2018
6.8 years
April 19, 2006
January 26, 2017
April 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery
A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor
Up to 5 years
Secondary Outcomes (6)
Utility of Early PET Imaging in Predicting Response to Treatment
Up to 55 days
Disease-free Survival
Up to 5 years
Overall Survival
Up to 5 years
Patterns of Failure
Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis
Up to 5 years
- +1 more secondary outcomes
Study Arms (1)
Treatment (chemotherapy, chemoradiotherapy, surgery)
EXPERIMENTALINDUCTION 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.
Interventions
Undergo Surgery
Undergo radiation
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, 46601, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, 04074, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, 03301, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, 03103, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240, United States
Mountainview Medical
Berlin Corners, Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David H. Ilson, M.D., Ph.D.
- Organization
- Memorial Sloan-Kettering Cancer Center
Study Officials
- STUDY CHAIR
David H. Ilson, MD, PhD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2006
First Posted
April 21, 2006
Study Start
February 1, 2006
Primary Completion
December 1, 2012
Study Completion
October 15, 2014
Last Updated
May 8, 2018
Results First Posted
March 15, 2017
Record last verified: 2018-04