Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
NCT ID: NCT00420394
Last Updated: 2007-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Chemotherapy
surgery
radiotherapy
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Soroka University Medical Center
OTHER
Principal Investigators
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Margarita Tokar, MD
Role: STUDY_CHAIR
Soroka University Medical Center and Ben-Gurion University of the Negev
Locations
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Soroka University Medical Center,Oncology Center
Beersheba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SOR446006ctil
Identifier Type: -
Identifier Source: org_study_id