Phase 3
N=530
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01515748 ↗Enrolled (actual)
530
Serious AEs
36.5%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 — 60.24; 66.82 percentage of participants — p=0.0152
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Docetaxel (XRP6976) (Drug); Oxaliplatin (SR96669) (Drug); S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 |
60.24; 66.82 | 0.0152 sig |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Number of Participants With Post-Operative Pathological Stage Response |
0; 23; 9; 32; 18; 23 | — |
| SECONDARY Percentage of Participants With R0 Resection |
83.74; 95.50 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
190; 237; 57; 102; 11; 25 | — |
| SECONDARY Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 |
0; 0; 0; 4; 1; 1 | — |
| SECONDARY Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 |
1; 7; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 |
0; 0; 0; 0; 0; 0 | — |
Summary
Primary Objective:
- To compare the 3-year progression free survival (PFS) in the two treatment arms.
Secondary Objectives:
* Overall survival (OS).
* Postoperative pathological stage and R0 (complete) resection rate.
* Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.
Eligibility Criteria
Inclusion criteria
- Participants with new histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable.
- Participants with clinical stage (T2-3/N(+), T4/N(+/-):N positive means greater than or equal to [>=] 8 in hour axis).
- Signed informed consent.
Exclusion criteria
- Aged less than ( = 76 years. Performance status >=2 in Eastern Cooperative Oncology Group (ECOG) scale
- The participants who had the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which had been already successfully treated.
- Previous surgery on neoplasm of stomach.
- Participants who did not completely recovered from surgery.
- Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study.
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer.
- Participants with active infection or sepsis.
- Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of S-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery.
- Greater than or equal to grade 2 severe tumour haemorrhage.
- Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study.
- Pregnant or lactating participants.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01515748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.