Status:
UNKNOWN
Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection
Lead Sponsor:
Zhongnan Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Informed consent signed.;
- Age: 18-70 years old, sex is not restricted;
- 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;
- Received D0 or D1 operation, no tumor residual (R0);
- Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;
- ECOG 0-2;
- Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;
- 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;
- Renal function: serum creatinine is less than 1.5 \* ULN, and creatinine clearance rate is more than 60ml/min;
- No previous chemotherapy or radiation therapy history;
- No organ transplant history;
- Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;
- 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
- Received D2 radical operation;
- Tumor residual (R1/R2);
- There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;
- Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;
- Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;
- Anticipate other clinical trials in four weeks before enrollment.
- Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.
- Drug abuse history or alcohol addiction;
- Active infection existed.
- with severe malnutrition or severe anemia;
- Human immunodeficiency virus (HIV) infection;
- Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;
- Can not tolerate this study or may be allergic to the drug used in this study;
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03392103
Start Date
January 1 2017
End Date
December 1 2019
Last Update
January 5 2018
Active Locations (1)
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1
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, China, 430071