PREACT Study: Locally Advanced Gastric Cancer, Chemoradiotherapy vs. Chemotherapy Followed by D2 Surgery and Adjuvant Chemotherapy (PREACT)

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    682
  • sponsor
    Shanghai Cancer Hospital, China
Updated on 24 February 2022
platelet count
gastrectomy
cancer
serum bilirubin
oxaliplatin
chemoradiotherapy
gastric adenocarcinoma
neutrophil count
chemotherapy regimen
gastric cancer
cancer chemotherapy
adenocarcinoma
curative surgery
adjuvant chemotherapy
tegafur
immunomodulator
immunostimulants
gastric resection
pre-operative chemotherapy
gimeracil
tegafur-gimeracil-oteracil potassium

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.

Details
Condition Stomach Neoplasm, GastroEsophageal Cancer, Adenocarcinoma, Locally Advanced Cancer, Chemoradiation
Treatment Oxaliplatin, tegafur-gimeracil-oteracil potassium, Chemoradiotherapy, Gastric resection
Clinical Study IdentifierNCT03013010
SponsorShanghai Cancer Hospital, China
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
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