Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

June 19, 2007 updated by: Soroka University Medical Center

Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-sheva, Israel
        • Recruiting
        • Soroka University Medical Center,Oncology Center
        • Contact:
        • Sub-Investigator:
          • Konstantin Lavrenkov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility of the study regimen.

Secondary Outcome Measures

Outcome Measure
Rate of R0 resection following chemotherapy.
Morbidity and mortality of surgery following chemotherapy.
Overall and progression free survival following the study treatment plan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Study Chair: Margarita Tokar, MD, Soroka University Medical Center and Ben-Gurion University of the Negev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

June 20, 2007

Last Update Submitted That Met QC Criteria

June 19, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR446006ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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