NCT03001726

Brief Summary

Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

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
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

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

December 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 6, 2022

Status Verified

December 1, 2016

Enrollment Period

5.4 years

First QC Date

December 21, 2016

Last Update Submit

May 1, 2022

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

    through study completion, an average of 2 year

Secondary Outcomes (1)

  • progression-free survival

    through study completion, an average of 1 year

Other Outcomes (2)

  • response rate

    through study completion, an average of 24 weeks

  • adverse events

    through study completion, an average of 1 year

Study Arms (2)

Gastrectomy plus chemotherapy

In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Procedure: GastrectomyDrug: oxaliplatinDrug: S1Drug: Docetaxel

chemotherapy alone

Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.

Drug: oxaliplatinDrug: S1Drug: Docetaxel

Interventions

GastrectomyPROCEDURE

In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Gastrectomy plus chemotherapy
oxaliplatinDRUG

oxaliplatin 100 mg/m2

Also known as: Eloxatin
Gastrectomy plus chemotherapychemotherapy alone
S1DRUG

S1 40mg/m2

Also known as: tegafur
Gastrectomy plus chemotherapychemotherapy alone
DocetaxelDRUG

docetaxel 40 mg/m2

Also known as: Taxotere
Gastrectomy plus chemotherapychemotherapy alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical diagnosis of gastric cancer with a single non-curable factor

You may qualify if:

  • Clinical diagnosis of gastric cancer with a single non-curable factor
  • A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.

You may not qualify if:

  • Patients who can have radical resection.
  • Patietns who have more than one metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

  • Cui Y, Yu Y, Zheng S, Ying J, Du Y, Wang Y, Wang X, Shen Z, Liu F, Lv M, Sun Y, Liu T. Does resection after neoadjuvant chemotherapy of docetaxel, oxaliplatin, and S-1 (DOS regimen) benefit for gastric cancer patients with single non-curable factor? a multicenter, prospective cohort study (Neo-REGATTA). BMC Cancer. 2023 Apr 4;23(1):308. doi: 10.1186/s12885-023-10773-x.

    PMID: 37016303DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

GastrectomyOxaliplatinS 1 (combination)TegafurDocetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeCoordination ComplexesOrganic ChemicalsFluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Tianshu Liu, Physician

    Zhongshan Hopital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman for the department of oncology

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 23, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2022

Study Completion

December 1, 2023

Last Updated

May 6, 2022

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)