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

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: Raltitrexed; Radiation: postoperative radiotherapy

• Registration Number: NCT03392103
• Lead Sponsor: Zhongnan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2018-01-04
• Last Update Submitted: 2018-01-04
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
postoperative CRT	postoperative radiotherapy	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).
postoperative CRT	Raltitrexed	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).

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Zhongnan Hopital of Wuhan University; 🇨🇳 Wuhan, Hubei, China