- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03013010
PREACT Study: Locally Advanced Gastric Cancer, Chemoradiotherapy vs. Chemotherapy Followed by D2 Surgery and Adjuvant Chemotherapy (PREACT)
A Randomized, Controlled, Multicenter Study to Compare Preoperative Radiochemotherapy With Preoperative Chemotherapy in Patients With Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma (PREACT Study)
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Zhen Zhang, M.D.
- Phone Number: (86)13661738625
- Email: zhenzhang6@gmail.com
Study Contact Backup
- Name: Xiao-wen Liu, M.D.
- Phone Number: (86)13636698200
- Email: liuxw1129@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Zhen Zhang, M.D.
- Phone Number: (86)13661738625
- Email: zhenzhang6@gmail.com
-
Contact:
- Xiaowen Liu, M.D.
- Phone Number: (86)13636698200
- Email: liuxw1129@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >=18 years
- Female and male
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy >=6 months
- Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (GEJ) (excluding Siewert I) that is: Stage IIB (T3N1 only), IIIA (T2N3 not eligible), IIIB, and IIIC, i.e. T3 - T4a and node positive, or T4b and/ or node positive, according to American Joint Committee on Cancer (AJCC) 7th edition
- Considered operable following initial staging investigations or after pre-operative therapy Disease which can be radically treated with radiotherapy to 45 Gy with standard fractionation
- Adequate organ function defined as follows:
- Bone marrow: Haemoglobin >=90 g/L, Absolute neutrophil count (ANC) >=1.5 x 109 /L, Platelet count >=100 x 109 /L; Hepatic: Serum bilirubin <=1.5 x upper limit of normal, aspartate aminotransferase (AST) and/or alanine transaminase (ALT) <=2.5 x upper limit of normal; Renal: Serum creatinine <=1.0 x upper limit of normal
- Patients are willing to obey the treatment and provide blood and tissue specimens
- Written informed consent obtained before randomization
Exclusion Criteria:
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
- Sexually active males or females refuse to practice contraception during the study until 30 days after end of study
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer in the 5 years before randomization except for the squamous or basal cell carcinoma of the skin that has been effectively treated, and carcinoma in situ of the cervix that has been treated by operation
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease
- Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency
- Concurrent severe infection
- Severe gastrointestinal bleeding, gastrointestinal perforation
- Unable to swallow
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
- Known hypersensitivity reaction or metabolic disorder to S-1or oxaliplatin
- Renal impairment (GFR <=50ml/min)
- Linitis plastica
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Preoperative radiochemotherapy
1 cycle preoperative chemotherapy with S-1(Tegafur-Gimeracil-Oteracil Potassium)+ oxaliplatin. 5 weeks preoperative chemoradiotherapy. 1 cycle preoperative chemotherapy with S-1(Tegafur-Gimeracil-Oteracil Potassium)+ oxaliplatin. Gastric resection. 3 cycles adjuvant chemotherapy with S-1(Tegafur-Gimeracil-Oteracil Potassium)+ oxaliplatin. |
The dose of S-1 is according to body-surface area (BSA): patients with a BSA of less than 1.25 m2 received 80 mg daily; those with a BSA of 1.25 m2 or more but less than 1.5 m2 received 100 mg daily; and those with a BSA of 1.5 m2 or more received 120 mg daily.
oxaliplatin 130mg/m2, intravenously, on day 1.
Other Names:
Chemotherapy: S-1 40-60mg/m2 orally, oral tablet twice daily, days 1-5 of each week of radiotherapy. Radiotherapy: 45 Gy of radiation in 25 fractions, five days per week for five weeks.
Other Names:
A standard D2 gastrectomy was recommended.
The type of gastrectomy performed depended on the location and extent of the primary lesion.
For middle third tumors, the gastric margin was recommended to be more than 5 cm, and a total gastrectomy was performed.
For lower third tumors, a 2 cm duodenal margin was recommended and a subtotal or total gastrectomy was considered.
For upper third tumors, a 3 cm esophageal margin was recommended and a total gastrectomy or esophagogastrectomy was performed.
Billroth I or Roux-en-y gastrojejunostomy was performed for distal gastrectomy patients, Roux-en-y esophagojejunostomy was performed for total gastrectomy patients.
Other Names:
The dose of oxaliplatin is according to body-surface area (BSA): 130mg/m2, intravenously, on day 1.
|
ACTIVE_COMPARATOR: Preoperative chemotherapy
3 cycles preoperative chemotherapy with S-1(Tegafur-Gimeracil-Oteracil Potassium)+ oxaliplatin. Gastric resection. 3 cycles adjuvant chemotherapy with S-1(Tegafur-Gimeracil-Oteracil Potassium)+ oxaliplatin. |
The dose of S-1 is according to body-surface area (BSA): patients with a BSA of less than 1.25 m2 received 80 mg daily; those with a BSA of 1.25 m2 or more but less than 1.5 m2 received 100 mg daily; and those with a BSA of 1.5 m2 or more received 120 mg daily.
oxaliplatin 130mg/m2, intravenously, on day 1.
Other Names:
A standard D2 gastrectomy was recommended.
The type of gastrectomy performed depended on the location and extent of the primary lesion.
For middle third tumors, the gastric margin was recommended to be more than 5 cm, and a total gastrectomy was performed.
For lower third tumors, a 2 cm duodenal margin was recommended and a subtotal or total gastrectomy was considered.
For upper third tumors, a 3 cm esophageal margin was recommended and a total gastrectomy or esophagogastrectomy was performed.
Billroth I or Roux-en-y gastrojejunostomy was performed for distal gastrectomy patients, Roux-en-y esophagojejunostomy was performed for total gastrectomy patients.
Other Names:
The dose of oxaliplatin is according to body-surface area (BSA): 130mg/m2, intravenously, on day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: up to 3 years
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: up to 3 years
|
up to 3 years
|
Surgical complete resection rate (R0)
Time Frame: at the time of surgery
|
at the time of surgery
|
Pathological response rate
Time Frame: at the time of surgery
|
at the time of surgery
|
Proportion of patients with toxicities
Time Frame: up to 3 years
|
up to 3 years
|
Proportion of patients with surgery-related complication
Time Frame: at the time of surgery
|
at the time of surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ya-nong Wang, M.D., Fudan University
- Principal Investigator: Zhen Zhang, M.D., Fudan University
Publications and helpful links
General Publications
- Liu X, Jin J, Cai H, Huang H, Zhao G, Zhou Y, Wu J, Du C, Long Z, Fang Y, Ma M, Li G, Zhou M, Yin J, Zhu X, Zhu J, Sheng W, Huang D, Zhu H, Zhang Z, Lu Q, Xie L, Zhang Z, Wang Y. Study protocol of a randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma: PREACT. BMC Cancer. 2019 Jun 20;19(1):606. doi: 10.1186/s12885-019-5728-8.
- Liu X, Cai H, Sheng W, Huang H, Long Z, Wang Y. microRNAs expression profile related with response to preoperative radiochemotherapy in patients with locally advanced gastric cancer. BMC Cancer. 2018 Oct 29;18(1):1048. doi: 10.1186/s12885-018-4967-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Oxaliplatin
- Tegafur
Other Study ID Numbers
- FUSCC-LAGCCS002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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