NCT03427684

Brief Summary

Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.

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
18

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started May 2016

Typical duration for phase_1 gastric-cancer

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

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

January 28, 2018

Last Update Submit

February 8, 2018

Conditions

Gastric CancerChemoradiation

Keywords

Gastric cancerChemo-radiotherapyPhase I studyHypo-fractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose AND Dose limited toxicity

    To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy

    From date of enrollment until one month after chemo-radiotherapy

Secondary Outcomes (2)

  • Response rate

    From date of enrollment until surgery, assessed up to 2 months

  • 2-year disease-free survival

    From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months

Study Arms (1)

Hypo-fractionated radiotherapy

EXPERIMENTAL

Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer

Radiation: Hypo-fractionated radiotherapyDrug: S1

Interventions

Hypo-fractionated radiotherapyRADIATION

Hypo-fractionated radiotherapy with fraction \>2Gy .

Hypo-fractionated radiotherapy
S1DRUG

S-1 80mg/m2/day, orally intake on radiotherapy days.

Hypo-fractionated radiotherapy

Eligibility Criteria

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

You may qualify if:

  • Clinical stage T3-4N+M0
  • Gastric cancer or Siewert II/III esophagogastric junction carcinoma;
  • Pathologically confirmed adenocarcinoma;
  • years old, male or female;
  • Karnofsky score \>= 70;
  • White blood cell count \>= 4 x 109 / L; platelet count \>= 100 x109/L; serum creatinine =\< 1 x upper limit of normal, total bilirubin =\< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =\< 2.5 x upper limit of normal, alkaline phosphatase =\< 5 x upper limit of normal.

You may not qualify if:

  • Any chemotherapy or radiotherapy history before enrollment
  • Siewert I EGJ cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (2)

  • Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.

    PMID: 35219300DERIVED

  • Li N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9.

    PMID: 30089457DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jing Jin, MD

CONTACT

8610-87787658jinjing1025@csco.org.cn

Ning Li, MD

CONTACT

8610-87787625lee_ak@163.com

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
Principal Investigator

Study Record Dates

First Submitted

January 28, 2018

First Posted

February 9, 2018

Study Start

May 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2020

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations

CN(1)