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Status unknownNCT00420394Updated Jun 20, 2007

Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

A Phase 2 interventional study of Chemotherapy and surgery in Stomach Neoplasms, sponsored by Soroka University Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-06-20.

Sponsored by Soroka University Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Stomach Neoplasms

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Keywords

  • Neoadjuvant chemotherapy
  • Adjuvant chemoradiotherapy
  • Adenocarcinoma of stomach and gastroesophageal junction
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's planned enrollment of 30 is below the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • ProcedureChemotherapy
  • Proceduresurgery
  • Procedureradiotherapy
06

What researchers measure

Primary outcomes

  1. Feasibility of the study regimen.

Secondary outcomes

  1. Rate of R0 resection following chemotherapy.

  2. Morbidity and mortality of surgery following chemotherapy.

  3. Overall and progression free survival following the study treatment plan

07

Study locations

1 of 1 sites recruiting
  • Soroka University Medical Center,Oncology Center
    Beer-sheva, Israel
    • margarita Tokar, MD · Contact · ritato@clalit.org.il · +972-86400768
    • Konstantin Lavrenkov, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00420394
Lead sponsor
Soroka University Medical Center
First posted
Jan 11, 2007
Start date
Apr 2007
Last update
Jun 20, 2007

Study contacts

Margarita Tokar, MD
Contact
Ritato@clalit.org.il
+972-8-6400768
Dmitri Bobilev, MD
Contact
dmitrib@bgu.ac.il
+972-8-6400295
Margarita Tokar, MD
study chair · Soroka University Medical Center and Ben-Gurion University of the Negev

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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