CompletedPhase 3

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

China204 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 metastat…

What they're measuring

Disease free survival

Timeframe: up to 3 years

Trial details

NCT IDNCT03013010

SponsorShanghai Cancer Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-05