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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392103
Recruitment Status : Unknown
Verified December 2017 by Zhou Fuxiang, Zhongnan Hospital.
Recruitment status was:  Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Zhou Fuxiang, Zhongnan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Raltitrexed Radiation: postoperative radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: Raltitrexed
concurrent chemotherapy
Other Name: Raltitrexed Injectable Solution

Radiation: postoperative radiotherapy
concurrent postoperative radiation therapy
Other Name: adjuvant radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. The ratio of patients occured Grade 3 or higher adverse events [ Time Frame: From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT. ]

Secondary Outcome Measures :
  1. 2-year local-regionally recurrence rate [ Time Frame: 2 year ]
    The probability of locally and/or regionally recurrence at 2 year after CRT on imaging or pathological examination.

  2. 3-year local-regionally recurrence rate [ Time Frame: 3 year ]
    The probability of locally and/or regionally recurrence at 3 year after CRT on imaging or pathological examination.

  3. 2-year disease-free survival probability [ Time Frame: 2 year ]
    The probability of staying free from recurrence at 2 year after CRT on imaging or pathological examination.

  4. 3-year disease-free survival probability [ Time Frame: 3 year ]
    The probability of staying free from recurrence at 3 year after CRT on imaging or pathological examination.

  5. 2-year overall survival probability [ Time Frame: 2 year ]
    The probability of staying alive at 2 year after CRT.

  6. 3-year overall survival probability [ Time Frame: 3 year ]
    The probability of staying alive at 3 year after CRT.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392103


Contacts
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Contact: Jing Dai, M.D. +86（0）2767813155 daijing1116@163.com
Contact: Ling Xai, M.D. +86（0）2767813155 22425583@qq.com

Locations
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China, Hubei
Zhongnan Hopital of Wuhan University Recruiting
Wuhan, Hubei, China, 430071
Contact: Fuxiang Zhou, M.D.    +86（0）2767813155    fuxiang.zhou@whu.edu.cn   
Contact: Jing Dai, M.D.    +86（0）2767813155    daijing1116@163.com   
Sponsors and Collaborators
Zhongnan Hospital
Investigators
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Study Chair: Fuxiang Zhou, M.D. Wuhan University
More Information
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Responsible Party: Zhou Fuxiang, Principal Investigator, Clinical Professor, Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT03392103    
Other Study ID Numbers: HCCSC G03
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhou Fuxiang, Zhongnan Hospital:
Raltitrexed
IMRT
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Raltitrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors