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

NCT03392103 | Unknown Phase 2 DMC

• 1 other identifier: HCCSC G03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Raltitrexed; IMRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 2-year local-regionally recurrence rate

  2 year

• 3-year local-regionally recurrence rate

  3 year

• 2-year disease-free survival probability

  2 year

• 3-year disease-free survival probability

  3 year

• 2-year overall survival probability

  2 year

Study Arms (1)

postoperative CRT

EXPERIMENTAL

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; Radiation: postoperative radiotherapy

Interventions

Raltitrexed DRUG

concurrent chemotherapy

Also known as: Raltitrexed Injectable Solution

postoperative CRT

postoperative radiotherapy RADIATION

concurrent postoperative radiation therapy

Also known as: adjuvant radiotherapy

postoperative CRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed.;
• Age: 18-70 years old, sex is not restricted;
• 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;
• Received D0 or D1 operation, no tumor residual (R0);
• Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;
• ECOG 0-2;
• Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;
• 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;
• Renal function: serum creatinine is less than 1.5 \* ULN, and creatinine clearance rate is more than 60ml/min;
• No previous chemotherapy or radiation therapy history;
• No organ transplant history;
• Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;
• 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

You may not qualify if:

• Received D2 radical operation;
• Tumor residual (R1/R2);
• There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;
• Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;
• Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;
• Anticipate other clinical trials in four weeks before enrollment.
• Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.
• Drug abuse history or alcohol addiction;
• Active infection existed.
• with severe malnutrition or severe anemia;
• Human immunodeficiency virus (HIV) infection;
• Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;
• Can not tolerate this study or may be allergic to the drug used in this study;
• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

raltitrexed; Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Fuxiang Zhou, M.D.

  Zhongnan Hospital

  STUDY CHAIR

Central Study Contacts

Jing Dai, M.D.

CONTACT

+86（0）2767813155; daijing1116@163.com

Ling Xai, M.D.

CONTACT

+86（0）2767813155; 22425583@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 5, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 5, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)