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

January 4, 2018 updated by: Zhou Fuxiang, Zhongnan Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ling Xai, M.D.
  • Phone Number: +86（0）2767813155
  • Email: 22425583@qq.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hopital of Wuhan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Raltitrexed Injectable Solution
Radiation: postoperative radiotherapy
concurrent postoperative radiation therapy
Other Names:
  • adjuvant radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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
Time Frame: 2 year
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
Time Frame: 3 year
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
Time Frame: 2 year
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
Time Frame: 3 year
The probability of staying free from recurrence at 3 year after CRT on imaging or pathological examination.
3 year
2-year overall survival probability
Time Frame: 2 year
The probability of staying alive at 2 year after CRT.
2 year
3-year overall survival probability
Time Frame: 3 year
The probability of staying alive at 3 year after CRT.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Study Chair: Fuxiang Zhou, M.D., Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCCSC G03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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