NCT04135781

Brief Summary

This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
616

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2020

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

4.7 years

First QC Date

October 20, 2019

Last Update Submit

March 18, 2020

Conditions

Stomach Cancer

Keywords

nab-paclitaxelgastric cancer

Outcome Measures

Primary Outcomes (1)

  • 3 years Diseases-free Survival rate(3 years-DFS)

    DFS is defined as time from the date of inclusion up to the date of disease progression or death

    up to 3 years

Secondary Outcomes (2)

  • Overall survival (OS)

    up to 3 years

  • Safety as measured by number and grade of adverse events

    up to 3 years

Study Arms (2)

AS

EXPERIMENTAL

Arm A：nab paclitaxel （120mg/m2；iv；d1，8）+S-1 （\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）Q3W；up to eight cycles

Drug: nab paclitaxelDrug: Tegafur

XELOX

ACTIVE COMPARATOR

Arm B：Capetabine（1000 mg/m2 po, d1-14 bid ）+ Oxaliplatin（130mg/m2 , iv, d1）Q3W；up to eight cycles

Drug: OxaliplatinDrug: Capecitabine

Interventions

nab paclitaxelDRUG

nab paclitaxel （120mg/m2；iv；d1，8）

Also known as: albumin bound paclitaxel
AS
TegafurDRUG

S-1 （\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）

Also known as: S-1
AS
OxaliplatinDRUG

Oxaliplatin（130mg/m2 , iv, d1）

XELOX
CapecitabineDRUG

Capetabine（1000 mg/m2 po, d1-14 bid ）

XELOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18-75 years;
  • Histological diagnosis of stage III gastric adenocarcinoma and Gastroesophageal junction of the stomach;
  • Patients are required to provide a pathologically confirmed diagnosis report and provide 4-5 histological white films obtained at baseline;;
  • Patients underwent D2 radical resection within 6 weeks prior to random enrollment; and R0 resection criteria were achieved;
  • Ability to perform chemotherapy within 7 days of enrollment in the randomized group;
  • No prior anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy for primary lesions;
  • ECOG performance status of 0-1;
  • Haematological status: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥100×109 /L, hemoglobin(HB) ≥90 g/L;WBC ≥3.0×109 /L;And no bleeding tendency;
  • Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), alkaline phosphatase ≤2.5 x upper limit of normal range (ULN)；total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤3 x upper limit of normal range (ULN) when with Gilbert's syndrome;
  • kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance \>60 ml/min (calculated according to Cockroft-Gault)
  • Able and willing to comply with the study plans in this protocol and sign the informed consent;

You may not qualify if:

  • Treat with any other study drug or participate in another clinical trial with therapeutic intent within 28 days prior to enrollment;
  • postoperative complications requiring clinical intervention and affecting treatment, such as stomach cramps, dumping syndrome;
  • Patients known to be allergic or intolerant to clinical trial drugs;
  • investigator believes will affect the subject's treatment regimen, uncontrolled serious medical diseases, including severe heart disease (such as the New York Heart Association (NYHA) Level II or more Congestive heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection；
  • Known active infection with HIV, hepatitis B or hepatitis C;
  • Other serious and uncontrolled non-malignant disease; except adequately treated cervical carcinoma in situ, non-melanoma skin Localized prostate cancer after cancer and radical surgery (PSA ≤ 10 ng/ml); no recurrence or metastasis was found based on imaging follow-up results and any disease-specific tumor markers;
  • accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation;
  • Female patients during pregnancy or lactation, who are refused to receive contraception during the childbearing age;
  • The investigator judges patients who are not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

  • Cheng X, Wu D, Xu N, Chen L, Yan Z, Chen P, Zhou L, Yu J, Cui J, Li W, Wang C, Feng W, Wei Y, Yu P, Du Y, Ying J, Xu Z, Yang L, Zhang Y. Adjuvant albumin-bound paclitaxel combined with S-1 vs. oxaliplatin combined with capecitabine after D2 gastrectomy in patients with stage III gastric adenocarcinoma: a phase III multicenter, open-label, randomized controlled clinical trial protocol. BMC Cancer. 2021 Jan 12;21(1):56. doi: 10.1186/s12885-020-07772-7.

    PMID: 33435909DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

TaxesAlbumin-Bound PaclitaxelTegafurS 1 (combination)OxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsFluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Cheng xiangdong, PhD

    Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences

    STUDY CHAIR

Central Study Contacts

Cheng xiangdong, PhD

CONTACT

0571-88128041Chengxd516@126.com

Yu pengfei, PhD

CONTACT

0571-88128041ypfzmu@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 20, 2019

First Posted

October 23, 2019

Study Start

March 1, 2020

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)