NCT03977220

Brief Summary

Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started Jan 2020

Typical duration for phase_1 gastric-cancer

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

June 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

June 5, 2019

Last Update Submit

June 5, 2019

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Recommended dose for Phase II study

    through study completion, an average of 2 year

Study Arms (1)

Nab-paclitaxel combined with S-1

EXPERIMENTAL

Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Drug: Nab-paclitaxel combined with S-1

Interventions

Nab-paclitaxel combined with S-1DRUG

Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Nab-paclitaxel combined with S-1

Eligibility Criteria

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

You may qualify if:

  • gastric cancer patients after radical resection
  • diffuse type gastric cancer stage III

You may not qualify if:

  • Patients who have metastasis disease
  • Patients who can not tolerate chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cui Y, Yu Y, Yu S, Li W, Wang Y, Li Q, Liu T. Phase I study of adjuvant chemotherapy with nab-paclitaxel and S-1 for stage III Lauren's diffuse-type gastric cancer after D2 resection (NORDICA study). Cancer Med. 2023 Jan;12(2):1114-1121. doi: 10.1002/cam4.4966. Epub 2022 Jun 25.

    PMID: 35751496DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman for the department of oncology

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 6, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

June 6, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share