Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhongnan Hospital
• Treatments: Raltitrexed

Criteria

Inclusion Criteria:

1. Informed consent signed.;

2. Age: 18-70 years old, sex is not restricted;

3. Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation;

4. Received D0 or D1 operation, no tumor residual (R0);

5. Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;

6. ECOG 0-2;

7. Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;

8. Liver function: ALT or AST is less than or equal to 2.5 times of the normal high value (ULN); bilirubin is less than 1.5*ULN, serum APK is less than 2.5 * ULN;

9. Renal function: serum creatinine is less than 1.5 * ULN, and creatinine clearance rate is more than 60ml/min;

10. No previous chemotherapy or radiation therapy history;

11. No organ transplant history;

12. Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;

13. Men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before , during and after the course of the study

Exclusion Criteria:

1. Received D2 radical operation;

2. Tumor residual (R1/R2);

3. There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;

4. Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;

5. Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;

6. Anticipate other clinical trials in four weeks before enrollment.

7. Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.

8. Drug abuse history or alcohol addiction;

9. Active infection existed.

10. with severe malnutrition or severe anemia;

11. Human immunodeficiency virus (HIV) infection;

12. Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;

13. Can not tolerate this study or may be allergic to the drug used in this study;

14. Persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.