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A Randomized, Controlled, Multicenter Study to Compare Preoperative Radiochemotherapy With Preoperative Chemotherapy in Patients With Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma (PREACT)

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ClinicalTrials.gov Identifier: NCT03013010
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborators:
Fudan University
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Huadong Hospital
Information provided by (Responsible Party):
Shanghai Cancer Hospital, China

Brief Summary:
Although the incidence of gastric cancer has been substantially declining for several decades, it is still the sixth most common cancer and the fourth most frequent cause of cancer death worldwide. Surgery is still the only curative option for gastric cancer. However, most patients are unable to undergo surgery because of late stage, unresectable disease. The prognosis for these patients is very poor. Although the Magic trial showed that perioperative chemotherapy can increase the rate of curative surgery and significantly improve overall survival in patients with operable gastric or lower esophageal adenocarcinomas, no pCR events were reported in this trial. The intervention arm in PREACT consists of pre-operative chemotherapy, pre-operative radiochemotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery, and post-operative chemotherapy. The primary purpose of PREACT is to investigate whether the addition of radiochemotherapy to chemotherapy is superior to chemotherapy alone in the pre-operative setting in improving disease free survival in patients with locally advanced gastric or esophagogastric junction adenocarcinoma.

Condition or disease Intervention/treatment Phase
Stomach Neoplasm GastroEsophageal Cancer Adenocarcinoma Locally Advanced Cancer Chemoradiation Drug: Tegafur-Gimeracil-Oteracil Potassium Radiation: Chemoradiotherapy Procedure: Gastric resection Drug: Oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 682 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.

Drug: Tegafur-Gimeracil-Oteracil Potassium
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 Name: S-1

Radiation: Chemoradiotherapy

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 Name: radiochemotherapy

Procedure: Gastric resection
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 Name: Gastrectomy

Drug: Oxaliplatin
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.

Drug: Tegafur-Gimeracil-Oteracil Potassium
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 Name: S-1

Procedure: Gastric resection
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 Name: Gastrectomy

Drug: Oxaliplatin
The dose of oxaliplatin is according to body-surface area (BSA): 130mg/m2, intravenously, on day 1.




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]
  2. Surgical complete resection rate (R0) [ Time Frame: at the time of surgery ]
  3. Pathological response rate [ Time Frame: at the time of surgery ]
  4. Proportion of patients with toxicities [ Time Frame: up to 3 years ]
  5. Proportion of patients with surgery-related complication [ Time Frame: at the time of surgery ]


Information from the National Library of Medicine

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

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

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): NCT03013010


Contacts
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Contact: Zhen Zhang, M.D. (86)13661738625 Zhenzhang6@gmail.com
Contact: Xiao-wen Liu, M.D. (86)13636698200 liuxw1129@hotmail.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhen Zhang, M.D.    (86)13661738625    zhenzhang6@gmail.com   
Contact: Xiaowen Liu, M.D.    (86)13636698200    liuxw1129@hotmail.com   
Sponsors and Collaborators
Shanghai Cancer Hospital, China
Fudan University
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Huadong Hospital
Investigators
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Principal Investigator: Ya-nong Wang, M.D. Fudan University
Principal Investigator: Zhen Zhang, M.D. Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Cancer Hospital, China
ClinicalTrials.gov Identifier: NCT03013010     History of Changes
Other Study ID Numbers: FUSCC-LAGCCS002
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Shanghai Cancer Hospital, China:
Randomized
Open Label
Multicenter
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Tegafur
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action