Clinical trial NCT01815853: Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
Official title: An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Neoadjuvant
Chemoradiotherapy
Chemotherapy
Locally advanced gastric cancer
Pathological complete response
D2 gastrectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Liaoning Cancer Hospital & Institute
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Guangxi Medical University Cancer Center
name: Tianjin Medical University Cancer Institute and Hospital
name: Zhejiang Cancer Hospital
name: First Hospital of China Medical University
name: First People's Hospital of Hangzhou
First posted: 2013-03-21
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Disease-free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Pathological Complete Remission
timeFrame: Peri-operative period
measure: Radical Resection Rate
timeFrame: Peri-operative period
measure: Adverse effects
timeFrame: Peri-operative period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhi-wei Zhou, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: