Back to resultsPhase II Study of DC Versus 5-FU/CF as Chemotherapy and Concurrent Chemoradiotherapy for Locally Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DC
concurrent chemoradiotherapy with 5-FU/CF
radiation
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring concurrent chemoradiotherapy, FOLFOX6, chemotherapy, docetaxel, cisplatin, gastric cancer
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Age > 19
- Histologically proven gastric or gastroesophageal adenocarcinoma
- ≥ D2 lymph node dissection, curative gastrectomy,
- Stage T4 with or without any positive LN (AJCC 2010) ，No distant metastasis(M0) and after D2 radical gastrectomy
- KPS≥70 or ECOG 0-2
- R0 resection,
- Adequate bone marrow functions (WBC≥4.0×109/L，GRAN≥2.0×109/L，Hb≥90g/L, transfusion allowed, PLT≥100×109/L )
- No severe functional damage of major organ,and no uncontrolled or severe cardiopulmonary concurrent system disease
- Adequate renal functions(serum creatinine ≤ 1.5×ULN ) ;liver functions (serum bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.5 times(normal value) ,serum AKP≤2.5×ULN
- Predictive survival time longer than 6 months.
Exclusion Criteria:
- pregnant or breast-feeding women;
- Have received preoperative neoadjuvant therapy of gastric cancer
- Before or at the same time with other malignant tumor, and underwent chemotherapy, immune, and biological treatment and radiation therapy;with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- uncontrolled mental disease
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
- Active infection requiring antibiotics
- Resection margin (+) at permanent pathology
- Peripheral neuropathy symptoms, NCI class > 1
- severe malnutrition or severe anemia
- uncontrolled Primary brain tumors or the central nervous system disease
- Known hypersensitivity against any of the study drugs
- Pathologic stage I-IIa or IV (according to AJCC 2010)
- Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
Sites / Locations
- Zhongnan Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A
Arm B
Arm Description
chemotherapy regimen:Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles → 5-FU 400 mg/m2 IV and Leucovorin 20 mg/m2 IV on the first four and the last three days of radiotherapy + RT 45Gy (5weeks)→ Rest for 4 weeks →Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles. Radiation: concurrent chemoradiotherapy with 5-FU/CF.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks.
chemotherapy regimen:Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles → Docetaxel 35mg iv D1,Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy (5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles Radiation: concurrent chemoradiotherapy with DC.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks.
Outcomes
Primary Outcome Measures
Disease free survival
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 2 or 3 year disease free survival
Secondary Outcome Measures
Overall survival(OS)
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 3-year overall survival
Local and regional control rate
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as local and regional control rate
feasibility (including adverse events )
feasibility of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as toxicities and rate of patients complete concurrent chemoradiation according to protocol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01889303
Brief Title
Phase II Study of DC Versus 5-FU/CF as Chemotherapy and Concurrent Chemoradiotherapy for Locally Advanced Gastric Cancer
Official Title
Phase II Clinical Trial of Docetaxel Plus Cisplatin as Adjuvant Chemotherapy and Concurrent Chemoradiotherapy Versus FOLFOX6 as Adjuvant and 5-FU/CF as Chemoradiotherapy in Patients of Locally Advanced Gastric Cancer After Radical Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall survival and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surgical resection. However,there are still many patients experiencing local recurrence or distant metastasis after adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and standard regimen for adjuvant treatment has not been established in locally advanced gastric cancer yet.The investigators designed the trial to investigate the efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.
Detailed Description
In Intergroup 0116 trial, 5-FU plus CF regimen was used as adjuvant chemotherapy and concurrent chemoradiotherapy in patients with resected gastric cancer.But 33 percent of those in the chemoradiotherapy group had distant relapses. Docetaxel plus cisplatin regimen as adjuvant chemotherapy for gastric cancer has been proofed Safe and Effective in many clinical trials about gastric cancer. The purpose of this study is to evaluate efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical surgery. The investigators hope the new interventions can reduce the rate of distant metastasis and have more clinical benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
concurrent chemoradiotherapy, FOLFOX6, chemotherapy, docetaxel, cisplatin, gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
chemotherapy regimen:Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles → 5-FU 400 mg/m2 IV and Leucovorin 20 mg/m2 IV on the first four and the last three days of radiotherapy + RT 45Gy (5weeks)→ Rest for 4 weeks →Oxaliplatin 85mg/m2 IV d1,Leucovorin 400mg/m2 IV d1,5-FU 400mg/m2 IV bolus d1 ,then 2400mg/m2 over 46h continuous infusion Q2W for 3 cycles.
Radiation: concurrent chemoradiotherapy with 5-FU/CF.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
chemotherapy regimen:Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles → Docetaxel 35mg iv D1,Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy (5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W x 2 cycles
Radiation: concurrent chemoradiotherapy with DC.Radiotherapy consisted of 45Gy of radiation at 1.8Gy per day, five days per week for five weeks.
Intervention Type
Drug
Intervention Name(s)
DC
Other Intervention Name(s)
Docetaxel Injection， Hengrui Medicine
Intervention Description
Docetaxel plus cisplatin chemotherapy regimen was delivered as chemotherapy and concurrent chemoradiotherapy.
chemotherapy regimen: Docetaxel（Qilu Pharma. China） 75mg iv D1, Cisplatin（Qilu Pharma. China） 75mg iv D1 ,Q3W for 2 cycles, then Docetaxel 35mg iv D1, Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy( 5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W for 2 cycles.
Intervention Type
Drug
Intervention Name(s)
concurrent chemoradiotherapy with 5-FU/CF
Other Intervention Name(s)
Hengrui Medicine
Intervention Description
FOLFOX6 regiment was delivered as adjuvant chemotherapy and 5-FU/CF as concurrent chemotherapy treatment.
Adjuvant chemotherapy: FOLFOX6 regiment : Oxaliplatin（Hengrui Medicine Co., Ltd，China） 85mg/m2 IV d1, Leucovorin （Hengrui Medicine Co., Ltd，China）400mg/m2 IV d1, 5-FU（Hengrui Medicine Co., Ltd，China） 400mg/m2 IV bolus d1, followed with 2400mg/m2 over 46h continuous infusion Q2Wx3 cycles of chemotherapy Concurrent chemotherapy : 5-FU 400mg/m2 IV and Leucovorin 20mg/m2 IV were given on the first four and the last three days in the period of radiotherapy. After radiation, patients will have a rest lasting for 4 weeks and then given Folxof6 regiment chemotherapy for 3 cycles.
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
Therapy plan system was formulated by CT simulation. Radiation was delivered with 15MV photons in both Arm A and Arm B. Radiotherapy consisted of 45Gy of radiation at 1.8Gy/day, five days per week for 5 weeks, to the tumor bed, to the margins of resection, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
Primary Outcome Measure Information:
Title
Disease free survival
Description
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 2 or 3 year disease free survival
Time Frame
2,3 year
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 3-year overall survival
Time Frame
3 year
Title
Local and regional control rate
Description
efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as local and regional control rate
Time Frame
2,3 year
Title
feasibility (including adverse events )
Description
feasibility of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as toxicities and rate of patients complete concurrent chemoradiation according to protocol.
Time Frame
3year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Age > 19
Histologically proven gastric or gastroesophageal adenocarcinoma
≥ D2 lymph node dissection, curative gastrectomy,
Stage T4 with or without any positive LN (AJCC 2010) ，No distant metastasis(M0) and after D2 radical gastrectomy
KPS≥70 or ECOG 0-2
R0 resection,
Adequate bone marrow functions (WBC≥4.0×109/L，GRAN≥2.0×109/L，Hb≥90g/L, transfusion allowed, PLT≥100×109/L )
No severe functional damage of major organ,and no uncontrolled or severe cardiopulmonary concurrent system disease
Adequate renal functions(serum creatinine ≤ 1.5×ULN ) ;liver functions (serum bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.5 times(normal value) ,serum AKP≤2.5×ULN
Predictive survival time longer than 6 months.
Exclusion Criteria:
pregnant or breast-feeding women;
Have received preoperative neoadjuvant therapy of gastric cancer
Before or at the same time with other malignant tumor, and underwent chemotherapy, immune, and biological treatment and radiation therapy;with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
uncontrolled mental disease
Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
Active infection requiring antibiotics
Resection margin (+) at permanent pathology
Peripheral neuropathy symptoms, NCI class > 1
severe malnutrition or severe anemia
uncontrolled Primary brain tumors or the central nervous system disease
Known hypersensitivity against any of the study drugs
Pathologic stage I-IIa or IV (according to AJCC 2010)
Inadequate surgery including D0, D1 resection, dissected LNs less than 12
Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
F X Zhou, PHD
Phone
86-27-67813155
Email
happyzhoufx@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Y F Zhou, PHD
Organizational Affiliation
President of Zhongnan Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F X Zhou, PHD
Phone
86-27-67813155
Email
happyzhoufx@sina.com
First Name & Middle Initial & Last Name & Degree
Y F Zhou, PHD
Phone
86-27-67823096
Email
yfzhouwhu@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase II Study of DC Versus 5-FU/CF as Chemotherapy and Concurrent Chemoradiotherapy for Locally Advanced Gastric Cancer
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