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A randomized phase III trial of concurrent chemoradiotherapy consisting of S-1 and oxaliplatin (SOX) in gastric cancer with radical D2 lymph node dissection

A randomized phase III trial of concurrent chemoradiotherapy consisting of S-1 and oxaliplatin (SOX) in gastric cancer with radical D2 lymph node dissection

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002919
Enrollment
Unknown
Registered
2012-12-11
Start date
2012-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

group of concurrent chemoradiotherapy:concurrent chemoradiotherapy
Group of chemotherapy:chemoradiotherapy

Sponsors

Department of medical oncology, Cancer Center, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age from 18-75y; 2. Patient with postoperative gastric cancer and which was confirmed by positive pathological diagnosis; 3. R0 and D2 Radical Gastrectomy with organ preserved should be delivered (with organs reserves) (the numbers of dissected lymph nodes should be more than 15); 4. Within 3 mothes after operation; 5. Post-surgery stage >=T4a, N0-3, M0 according to 2010 edition UICC/AJCC staging; 6. ECOG: 0-1; 7. No radiotherapy or systematic chemotherapy was delivered before or after operation; 8.Function of main organs are normal: (1) The results of blood tests are normal (HB>=9g/l, N >=1.5*10^9/L, PLT>=100*10^9/l); (2) The results of Blood Biochemistry are normal: Crea, TB <=1.0 folders; ALT, AST<=2.5 folders; 9. Women of reproductive age must take pregnancy test (serum or urine)in the first seven days, and the result should be negative, and they should be willing to use appropriate methods for contraception during the trials and eight weeks after the treatment. Men should adopt operation sterilization or agree to use appropriate methods for contraception during the trials and eight weeks after the treatment; 10. Patients with good compliance and follow-up should participate in the trial voluntarily and should sign the informed agreement.

Exclusion criteria

Exclusion criteria: 1. Patient who has had the malignant tumor at present or before, except for cured basal cell carcinoma of skin or Cervical carcinoma in situ; 2. Pregnant or lactation women; 3. Serious heart disease, uncontrolled Diabetic; 4. psycologic disease; 5. Seriously or uncontrolled infection; 6. Allergy to S-1 or oxaliplatin; 7. Participant in another trial in the initial 4 weeks.

Design outcomes

Primary

MeasureTime frame
3y-disese free survival;

Secondary

MeasureTime frame
3y-overall survival;local control rate;

Countries

China

Contacts

Public ContactBi Feng
bifeng@medmail.com.cn+86 18980601771

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 17, 2026