SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer

Last updated: April 23, 2012
Sponsor: Lin Chen
Overall Status: Trial Status Unknown

Phase

3

Condition

Stomach Cancer

Gastric Ulcers

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT01583361
LCHEN-PLAGH
  • Ages 20-75
  • All Genders

Study Summary

This is a randomized, multicenter, controlled trial to prove efficacy of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.

The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed gastric adenocarcinoma

  2. Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled

  3. All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stageclassification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients canbe enrolled

  4. planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy

  5. KPS > 60; ECOG performance status 0-2

  6. Life expectancy > 6 months

  7. Age: 20 to 75 years

  8. No other severe disease and life expectancy less than five years

  9. 7 days before enrolled, baseline data should be finished including:

  • Granulocyte count ≥ 1.5×109/L;

  • platelet count ≥ 100×109/L;

  • Hemoglobin ≥ 90g/L;

  • hepatic < 1.5×ULN;

  • total bilirubin ≤ 1.0×ULN;

  • creatinine < 1.5×ULN;

  • PT-INR/PTT < 1.7× ULN

  1. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria

  2. Written informed consent and able to comply with the protocol

Exclusion

Exclusion Criteria:

  1. Patient cannot undergo surgery or chemotherapy because of other severe disease

  2. Be allergic to chemotherapy drugs

  3. Patients receiving any chemotherapy or drugs involved in this trial in four weeksbefore enrolled

  4. Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy orradiotherapy for gastric cancer

  5. Within the last 5 years in patients with a history of other malignant diseases

  6. Pregnant or breast-feeding women

  7. Severe heart disease like symptoms of coronary heart disease, New York HeartAssociation (NYHA) grade II or worse congestive heart failure or cardiac arrhythmiahaving medications or myocardial infarction within the last 12 months

  8. Patients with upper gastrointestinal obstruction or absorption anomaly; patient inobstruction of the Helicobacter pylori failure like effect S-1 to take and absorb

  9. Patients with a history of peripheral nerve disease

  10. Patients who get organ transplant

  11. lack of dihydropyrimidine dehydrogenase (DPD)

  12. Infection or other disease failure to control

Study Design

Total Participants: 772
Study Start date:
March 01, 2012
Estimated Completion Date:
January 31, 2017

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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