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Compares treatment options for Gastric Cancer (GC)
Official title Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer
ClinicalTrials.gov ID: NCT07366528
What this study is testing
What is Oxaliplatin plus S-1?
Oxaliplatin plus S-1 is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for gastric cancer (gc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- age 18 to 80 years old, male and female
- histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
- American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b...
- with no evidence of metastatic disease
You likely can't join if
- other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
- severe complications that may lead to an expected survival time less than 5 years
- uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
- allergic to study medication
- bowel obstruction or other conditions affecting oral administration
- organ functions that cannot tolerate study treatment
See the full eligibility criteria
- age 18 to 80 years old, male and female
- histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
- American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
- with no evidence of metastatic disease
- ECOG 0 to 1
- Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver...
- Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.
- Signed informed consent and willing to follow the study protocol
- other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
- severe complications that may lead to an expected survival time less than 5 years
- uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
- allergic to study medication
- bowel obstruction or other conditions affecting oral administration
- organ functions that cannot tolerate study treatment
- other conditions that patients are unsuitable for this study assessed by the investigators
The study team makes the final eligibility decision.
Where it's taking place
- Shaoguan, Guandong, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shaoguan, Guandong, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.