Adjuvant Chemotherapy Folfox Combined with Concurrent Radiotherapy in Postsurgery Gastric Cancer Patient: Phase II Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-12001918

Enrollment

Unknown

Registered

2012-01-30

Start date

2011-07-01

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

Single cohort:Oxaliplatin, 5-Fu, CF

Eligibility

Sex/Gender

All

Age

18 Years to 75 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; 4. Within 3 mothes after operation; 5. Post-surgery stage is T3-4, 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>=12g/l, WBC>=4.0*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 fluorouracil or oxaliplatin; 7. Participant in another trial in the initial 4 weeks.

Design outcomes

Primary

Measure	Time frame
Disease free survival;overall survival;	—

Secondary

Measure	Time frame
local control rate;local recurrent rate;Side effect;	—

Countries

China

Contacts

Public ContactWang Xin

wangxin77213@yahoo.com.cn+86 18980602291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026