Back to resultsPerioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Chemotherapy
surgery
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Neoadjuvant chemotherapy, Adjuvant chemoradiotherapy, Adenocarcinoma of stomach and gastroesophageal junction
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
- T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
- Disease must be clinically limited to the stomach or GEJ.
- Pre-treatment Port-a-Cath insertion obligatory
- No prior chemotherapy.
- No prior radiotherapy.
- Patients must be surgical candidates as determined by the treating surgeon.
- Adequate organ function defined as:
- Patients must have an ECOG Performance Status < 1.
- 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 and CT scanning.
- Patients with primary carcinomas of the esophagus.
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- Patients with evidence of metastatic disease are not eligible.
- New York Heart Association Class III or IV heart disease.
- Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
- Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
- Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
- Clinically significant hearing loss.
- 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 its requirements.
- Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study
Sites / Locations
- Soroka University Medical Center,Oncology CenterRecruiting
Outcomes
Primary Outcome Measures
Feasibility of the study regimen.
Secondary Outcome Measures
Rate of R0 resection following chemotherapy.
Morbidity and mortality of surgery following chemotherapy.
Overall and progression free survival following the study treatment plan
Full Information
NCT ID
NCT00420394
First Posted
January 9, 2007
Last Updated
June 19, 2007
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00420394
Brief Title
Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
Official Title
Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.
Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Neoadjuvant chemotherapy, Adjuvant chemoradiotherapy, Adenocarcinoma of stomach and gastroesophageal junction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Type
Procedure
Intervention Name(s)
radiotherapy
Primary Outcome Measure Information:
Title
Feasibility of the study regimen.
Secondary Outcome Measure Information:
Title
Rate of R0 resection following chemotherapy.
Title
Morbidity and mortality of surgery following chemotherapy.
Title
Overall and progression free survival following the study treatment plan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
Disease must be clinically limited to the stomach or GEJ.
Pre-treatment Port-a-Cath insertion obligatory
No prior chemotherapy.
No prior radiotherapy.
Patients must be surgical candidates as determined by the treating surgeon.
Adequate organ function defined as:
Patients must have an ECOG Performance Status < 1.
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 and CT scanning.
Patients with primary carcinomas of the esophagus.
Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
Patients with evidence of metastatic disease are not eligible.
New York Heart Association Class III or IV heart disease.
Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
Clinically significant hearing loss.
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 its requirements.
Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margarita Tokar, MD
Phone
+972-8-6400768
Email
Ritato@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitri Bobilev, MD
Phone
+972-8-6400295
Email
dmitrib@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Tokar, MD
Organizational Affiliation
Soroka University Medical Center and Ben-Gurion University of the Negev
Official's Role
Study Chair
Facility Information:
Facility Name
Soroka University Medical Center,Oncology Center
City
Beer-sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
margarita Tokar, MD
Phone
+972-86400768
Email
ritato@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Konstantin Lavrenkov, MD
12. IPD Sharing Statement
Learn more about this trial
Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
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