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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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postoperative CRT

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).

Group Type EXPERIMENTAL

Raltitrexed

Intervention Type DRUG

concurrent chemotherapy

postoperative radiotherapy

Intervention Type RADIATION

concurrent postoperative radiation therapy

Interventions

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Raltitrexed

concurrent chemotherapy

Intervention Type DRUG

postoperative radiotherapy

concurrent postoperative radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Raltitrexed Injectable Solution adjuvant radiotherapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No