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Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Soroka University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420394
First Posted: January 11, 2007
Last Update Posted: June 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  Purpose

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


Condition Intervention Phase
Stomach Neoplasms Procedure: Chemotherapy Procedure: surgery Procedure: radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

Estimated Enrollment: 30
Study Start Date: April 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
  2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
  3. Disease must be clinically limited to the stomach or GEJ.
  4. Pre-treatment Port-a-Cath insertion obligatory
  5. No prior chemotherapy.
  6. No prior radiotherapy.
  7. Patients must be surgical candidates as determined by the treating surgeon.
  8. Adequate organ function defined as:
  9. Patients must have an ECOG Performance Status < 1.
  10. Patients must be able to sign the informed consent document.

Exclusion Criteria:

  1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
  2. Patients with primary carcinomas of the esophagus.
  3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
  4. Patients with evidence of metastatic disease are not eligible.
  5. New York Heart Association Class III or IV heart disease.
  6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
  7. Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
  8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
  9. Clinically significant hearing loss.
  10. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
  11. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
  12. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420394


Contacts
Contact: Margarita Tokar, MD +972-8-6400768 Ritato@clalit.org.il
Contact: Dmitri Bobilev, MD +972-8-6400295 dmitrib@bgu.ac.il

Locations
Israel
Soroka University Medical Center,Oncology Center Recruiting
Beer-sheva, Israel
Contact: margarita Tokar, MD    +972-86400768    ritato@clalit.org.il   
Sub-Investigator: Konstantin Lavrenkov, MD         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Study Chair: Margarita Tokar, MD Soroka University Medical Center and Ben-Gurion University of the Negev
  More Information

ClinicalTrials.gov Identifier: NCT00420394     History of Changes
Other Study ID Numbers: SOR446006ctil
First Submitted: January 9, 2007
First Posted: January 11, 2007
Last Update Posted: June 20, 2007
Last Verified: January 2007

Keywords provided by Soroka University Medical Center:
Neoadjuvant chemotherapy
Adjuvant chemoradiotherapy
Adenocarcinoma of stomach and gastroesophageal junction

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases