A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02648841
• Other study ID #: NCC2015 YL-02
• Status: Recruiting
• Phase: Phase 3
• First received: January 4, 2016
• Last updated: January 5, 2016
• Start date: July 2015
• Est. completion date: June 2022

Study information

• Verified date: January 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Ning Li
• Phone: +86-87788280
• Email: lee_ak[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: June 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Gastric cancer;

• D2 and R0 resection;

• Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging);

• Karnofsky performance score (KPS) >= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1;

• Adequate blood counts: White blood cell count =3.5 x 109/L Haemoglobin levels =100g/L Platelet count =100 x 109/L Creatinine levels =1.0× upper normal limit(UNL) Urea nitrogen levels =1.0× upper normal limit(UNL) Alanine aminotransferase(ALT) =1.5× upper normal limit(UNL) Aspartate aminotransferase(AST) =1.5× upper normal limit(UNL) Alkaline phosphatase(ALP) =1.5× upper normal limit(UNL) Total bilirubin(TBIL) =1.5× upper normal limit(UNL)

• No allergic history of 5-Fu or Platinum drugs;

• No history of chemotherapy or other anti-cancer therapy;

• Informed consent should be signed.

Exclusion Criteria:

• GEJ adenocarcinoma

• Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)

• Allergic to Fluorouracil or Platinum drugs;

• Concurrent uncontrolled medical condition;

• Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;

• Severe postoperative complications such as anastomotic leakage, etc.;

• Symptoms or history of peripheral neuropathy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Radiation:
• Adjuvant Concurrent Chemo-radiotherapy
Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral.

Drug:
• Adjuvant chemotherapy for active comparator group
8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
• Adjuvant chemotherapy for experimental group
6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese academy of medical sciences	Bejing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3 years	No
Secondary	Local recurrence free survival		3 years	No
Secondary	Distant metastasis free survival		3 years	No
Secondary	Over all survival		3 years	No
Secondary	Adverse Event		3 years	No