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

• Sponsor: Zhongnan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03392103
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Jan 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 2-year local-regionally recurrence rate [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 [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 [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 [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 [2 year]

   The probability of staying alive at 2 year after CRT.

6. 3-year overall survival probability [3 year]

   The probability of staying alive at 3 year after CRT.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hopital of Wuhan University	Wuhan	Hubei	China	430071

Sponsors and Collaborators

• Zhongnan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhou Fuxiang, Principal Investigator, Clinical Professor, Zhongnan Hospital
• ClinicalTrials.gov Identifier: NCT03392103
• Other Study ID Numbers: HCCSC G03
• First Posted: Jan 5, 2018
• Last Update Posted: Jan 5, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Zhou Fuxiang, Principal Investigator, Clinical Professor, Zhongnan Hospital: Raltitrexed; IMRT
• Additional relevant MeSH terms: Stomach Neoplasms; Raltitrexed

Study Results

No Results Posted as of Jan 5, 2018