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Stomach NeoplasmPhase 3PREACTNCT03013010

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

A Phase 3 study testing Tegafur-Gimeracil-Oteracil Potassium, Chemoradiotherapy and Gastric resection in people with Stomach Neoplasm and GastroEsophageal Cancer, run by Shanghai Cancer Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tegafur-Gimeracil-Oteracil Potassium, Chemoradiotherapy and Gastric resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteChina
Study dates
Dec 2016to 5 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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)

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.

Being tested
Tegafur-Gimeracil-Oteracil Potassium, Chemoradiotherapy, Gastric resection, Oxaliplatin
Keywords
Randomized, Open Label, Multicenter
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tegafur-Gimeracil-Oteracil PotassiumDrug

    Also called S-1

    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.

  • ChemoradiotherapyRadiation

    Also called radiochemotherapy

    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.

  • Gastric resectionProcedure or surgery

    Also called Gastrectomy

    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.

  • OxaliplatinDrug

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

Study groups in NCT03013010
Study groupRoleWhat they receive
Preoperative radiochemotherapyExperimental1 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.
Receives: Drug: Tegafur-Gimeracil-Oteracil Potassium; Radiation: Chemoradiotherapy; Procedure: Gastric resection; Drug: Oxaliplatin
Preoperative chemotherapyActive comparator3 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.
Receives: Drug: Tegafur-Gimeracil-Oteracil Potassium; Procedure: Gastric resection; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival

    Measured: up to 3 years

Secondary outcomes (5)

  1. Overall survival

    Measured: up to 3 years

  2. Surgical complete resection rate (R0)

    Measured: at the time of surgery

  3. Pathological response rate

    Measured: at the time of surgery

  4. Proportion of patients with toxicities

    Measured: up to 3 years

  5. Proportion of patients with surgery-related complication

    Measured: at the time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completion5 Dec 2024
  4. Study completion5 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013010
Sponsor's protocol ID
FUSCC-LAGCCS002
Acronym
PREACT
Status last verified
Dec 2025
First submitted
4 Jan 2017
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.

    PubMed 40340830

  • 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.

    PubMed 31221115

  • 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.

    PubMed 30373600

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tegafur-Gimeracil-Oteracil Potassium, Chemoradiotherapy and Gastric resection in people with Stomach Neoplasm and GastroEsophageal Cancer, run by Shanghai Cancer Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03013010, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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