NCT05813015RecruitingPhase 3
Study of Comparing of With and Without Sequential Therapy of S-1
Comparison of With and Without Sequential Single Drug Therapy of S-1 After Adjuvant Chemotherapy With Docetaxel Plus S-1 in Stage III Gastric Cancer
Source: ClinicalTrials.gov · Last updated 14 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is: • The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy. All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 2 Apr 2023
- Start date
- 28 Jan 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Zhejiang University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05813015
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 70
- From 28 Jan 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (10) Those requiring immunosuppressive therapy for organ transplantation;
- (11) who have received other chemotherapy regimens
- (12) Those with uncontrolled severe infections, or other serious concomitant diseases;
Other illness
- (3) Those with a history of other malignant neoplastic disease in the last 5 years;
- (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications;
- (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months;
- (6) Severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc;
- (7) Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect S-1 absorption;
- (8) Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator;
- (9) Known to have peripheral nerve disease ≥ NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only;
- (13) Allergic to S-1 or any of the study drug components.
Other
- (1) Other pathological types of tumors;
- (2) Pregnant or nursing women;
Who the study is looking for
- (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;
- (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;
- (3) No significant tumor recurrence or metastasis as assessed by imaging;
- (4) Age 18 years - 75 years;
- (5) ECOG score of 0 or 1;
- (6) Laboratory tests tolerant to chemotherapy;
- (7) Hematological examination: no obvious signs of hematologic diseases, ANC ≥ 1.5 × 10\^9/L, platelet count ≥ 80 × 10\^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10\^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin \< 1.5 times the upper limit of normal value, AST, ALT \< 2.5 times the upper limit of normal value, creatinine \< 1.5 times the upper limit of normal value.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.