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Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer (Neo-CRAG)

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ClinicalTrials.gov Identifier: NCT01815853
Recruitment Status : Recruiting
First Posted : March 21, 2013
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Anhui Medical University
Liaoning Cancer Hospital & Institute
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangxi Medical University Cancer Center
Tianjin Medical University Cancer Institute & Hospital
Zhejiang Cancer Hospital
First Hospital of China Medical University
First People's Hospital of Hangzhou
Information provided by (Responsible Party):
Zhou Zhiwei, Sun Yat-sen University

Brief Summary:
Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety.

Condition or disease Intervention/treatment Phase
Gastric Cancer Radiation: Neoadjuvant Chemoradiotherapy Drug: Neoadjuvant Chemotherapy Procedure: R0 D2 Gastrectomy Drug: Adjuvant Chemotherapy Phase 3

Detailed Description:

Background: Literatures have shown that patitents with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patitents' outcome is still unclear.

Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy (Capecitabine 1000mg/m2, BID, D1-14; Oxaliplatin 130mg/m2 on day 1 for a 21-day cycle) or neoadjuvant chemotherapy alone using XELOX regimen following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma
Actual Study Start Date : June 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Neoadjuvant Chemoradiotherapy
Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 D1; 21-days/cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy
Radiation: Neoadjuvant Chemoradiotherapy
Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Procedure: R0 D2 Gastrectomy
Drug: Adjuvant Chemotherapy
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Active Comparator: Neoadjuvant Chemotherapy
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 D1; 21-days/cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy
Drug: Neoadjuvant Chemotherapy
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Procedure: R0 D2 Gastrectomy
Drug: Adjuvant Chemotherapy
3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)




Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 3 years ]
    3-year DFS


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    5-year Overall Survival

  2. Pathological Complete Remission [ Time Frame: Peri-operative period ]
    pCR

  3. Radical Resection Rate [ Time Frame: Peri-operative period ]
    R0 Resection Rate

  4. Adverse effects [ Time Frame: Peri-operative period ]
    Treatment safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consensus of the enrolled patients
  • being able to receive oral drug
  • from 18 to 75 years old
  • proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT3N2/N3M0, cT4aN+M0, cT4bNanyM0,
  • no prior other chemotherapy and/or radiation against the disease
  • normal function of all other vital organs including heart,liver ,kidney and so on
  • Eastern Cooperative Oncology Group performance status: 0~2

Exclusion Criteria:

  • history of other malignancy
  • allergic reaction to capecitabine or oxaliplatin
  • enrolled in other clinical trials
  • abnormal GI tract function
  • dysfunction of other organs
  • pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
  • other situations judged as not adaptive to the study by investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815853


Contacts
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Contact: Zhi-wei Zhou, M.D, Ph.D 0086-20-87343626 zhouzhw@sysucc.org.cn
Contact: Wei Wang, M.D, Ph.D 0086-20-87343910 wangwei@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Wei Wang, M.D, Ph.D    0086-20-87343910    wangwei@sysucc.org.cn   
Principal Investigator: Zhi-wei Zhou, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Anhui Medical University
Liaoning Cancer Hospital & Institute
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangxi Medical University Cancer Center
Tianjin Medical University Cancer Institute & Hospital
Zhejiang Cancer Hospital
First Hospital of China Medical University
First People's Hospital of Hangzhou
Investigators
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Principal Investigator: Zhi-wei Zhou, M.D, Ph.D Sun Yat-sen University

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Responsible Party: Zhou Zhiwei, Director of Gastric Surgery, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01815853    
Other Study ID Numbers: SYSUCCGPS2
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Zhou Zhiwei, Sun Yat-sen University:
Neoadjuvant
Chemoradiotherapy
Chemotherapy
Locally advanced gastric cancer
Pathological complete response
D2 gastrectomy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents