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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392103
• Other study ID #: HCCSC G03
• Status: Recruiting
• Phase: Phase 2
• First received: December 19, 2017
• Last updated: January 4, 2018
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Zhongnan Hospital
• Contact: Jing Dai, M.D.
• Phone: +86(0)2767813155
• Email: daijing1116[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Raltitrexed
concurrent chemotherapy

Radiation:
• postoperative radiotherapy
concurrent postoperative radiation therapy

Locations

Country	Name	City	State
China	Zhongnan Hopital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	2-year overall survival probability	The probability of staying alive at 2 year after CRT.	2 year
Secondary	3-year overall survival probability	The probability of staying alive at 3 year after CRT.	3 year