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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adjuvant Concurrent Chemo-radiotherapy
Adjuvant chemotherapy for active comparator group
Adjuvant chemotherapy for experimental group
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, adjuvant chemo-radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital, Chinese academy of medical sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adjuvant Chemotherapy

Adjuvant Chemo-radiotherapy

Arm Description

The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Local recurrence free survival
Distant metastasis free survival
Over all survival
Adverse Event

Full Information

First Posted
January 4, 2016
Last Updated
January 5, 2016
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02648841
Brief Title
A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, adjuvant chemo-radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
588 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Chemotherapy
Arm Type
Active Comparator
Arm Description
The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Arm Title
Adjuvant Chemo-radiotherapy
Arm Type
Experimental
Arm Description
The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Intervention Type
Radiation
Intervention Name(s)
Adjuvant Concurrent Chemo-radiotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Adjuvant chemotherapy for active comparator group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Adjuvant chemotherapy for experimental group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Local recurrence free survival
Time Frame
3 years
Title
Distant metastasis free survival
Time Frame
3 years
Title
Over all survival
Time Frame
3 years
Title
Adverse Event
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li
Phone
+86-87788280
Email
lee_ak@163.com
Facility Information:
Facility Name
Cancer Hospital, Chinese academy of medical sciences
City
Bejing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
+86-87788280
Email
lee_ak@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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