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

Study Overview
=================
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 resection.

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

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Raltitrexed
* Radiation: postoperative radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postoperative CRT<br>postoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4). | Drug: Raltitrexed<br>* concurrent chemotherapy<br>* Other names: Raltitrexed Injectable Solution;Radiation: postoperative radiotherapy<br>* concurrent postoperative radiation therapy<br>* Other names: adjuvant radiotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of patients occured Grade 3 or higher adverse events |  | From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year local-regionally recurrence rate | The probability of locally and/or regionally recurrence at 2 year after CRT on imaging or pathological examination. | 2 year | 
| 3-year local-regionally recurrence rate | The probability of locally and/or regionally recurrence at 3 year after CRT on imaging or pathological examination. | 3 year | 
| 2-year disease-free survival probability | The probability of staying free from recurrence at 2 year after CRT on imaging or pathological examination. | 2 year | 
| 3-year disease-free survival probability | The probability of staying free from recurrence at 3 year after CRT on imaging or pathological examination. | 3 year | 
| 2-year overall survival probability | The probability of staying alive at 2 year after CRT. | 2 year | 
| 3-year overall survival probability | The probability of staying alive at 3 year after CRT. | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Raltitrexed, IMRT