NCT00420394

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
Last Updated

June 20, 2007

Status Verified

January 1, 2007

First QC Date

January 9, 2007

Last Update Submit

June 19, 2007

Conditions

Stomach Neoplasms

Keywords

Neoadjuvant chemotherapyAdjuvant chemoradiotherapyAdenocarcinoma of stomach and gastroesophageal junction

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the study regimen.

Secondary Outcomes (3)

  • Rate of R0 resection following chemotherapy.

  • Morbidity and mortality of surgery following chemotherapy.

  • Overall and progression free survival following the study treatment plan

Interventions

ChemotherapyPROCEDURE
surgeryPROCEDURE
radiotherapyPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center,Oncology Center

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug TherapySurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Margarita Tokar, MD

    Soroka University Medical Center and Ben-Gurion University of the Negev

    STUDY CHAIR

Central Study Contacts

Margarita Tokar, MD

CONTACT

+972-8-6400768Ritato@clalit.org.il

Dmitri Bobilev, MD

CONTACT

+972-8-6400295dmitrib@bgu.ac.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

April 1, 2007

Last Updated

June 20, 2007

Record last verified: 2007-01

Locations

IL(1)