NCT04062058

Brief Summary

This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma

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
82

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Nov 2019

Typical duration for phase_2 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

First Submitted

Initial submission to the registry

August 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

August 18, 2019

Last Update Submit

January 20, 2022

Conditions

Gastric CancerNeoadjuvant Therapy

Keywords

gastric cancerneoadjuvant chemoradiotherapyneoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • PCR rate

    Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).

    6-8 months

Secondary Outcomes (4)

  • Acute chemotherapy/Chemoradiotherapy toxicities

    6-8 months

  • surgery complications

    6-8 months

  • Tumor down-staging

    6-8 months

  • R0 resection rate

    6-8 months

Study Arms (1)

Total Neoadjuvant Chemoradiotherapy

EXPERIMENTAL

Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery

Radiation: SIB-IMRTDrug: S-1Drug: SOXProcedure: Surgery

Interventions

SIB-IMRTRADIATION

45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target

Total Neoadjuvant Chemoradiotherapy
S-1DRUG

40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment

Total Neoadjuvant Chemoradiotherapy
SOXDRUG

SOX (S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)

Total Neoadjuvant Chemoradiotherapy
SurgeryPROCEDURE

Surgery, preferred D2 lymphadenectomy

Total Neoadjuvant Chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
  • No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
  • No prior abdominal or pelvic radiotherapy
  • Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
  • Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
  • Informed consent

You may not qualify if:

  • Any prior chemotherapy or other cancer treatment prior to this protocol
  • Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
  • With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
  • History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
  • Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
  • History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
  • History of prior radiation to the abdomen
  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, 100021, China

RECRUITING

Related Publications (3)

  • Shi JM, Li N, Jiang LM, Yang L, Wang SL, Song YW, Liu YP, Fang H, Lu NN, Qi SN, Chen B, Li YX, Zhao DB, Tang Y, Jin J. A prospective phase II clinical trial of total neoadjuvant therapy for locally advanced gastric cancer and gastroesophageal junction adenocarcinoma. Sci Rep. 2024 Mar 29;14(1):7522. doi: 10.1038/s41598-024-58177-6.

    PMID: 38553594DERIVED

  • Shi J, Li N, Tang Y, Jiang L, Yang L, Wang S, Song Y, Liu Y, Fang H, Lu N, Qi S, Chen B, Li Z, Liu S, Wang J, Wang W, Zhu S, Yang J, Li Y, Zhao D, Jin J. Total neoadjuvant therapy for locally advanced gastric cancer and esophagogastric junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase II clinical trial. BMC Gastroenterol. 2022 Jul 28;22(1):359. doi: 10.1186/s12876-022-02440-5.

    PMID: 35902798DERIVED

  • 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

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jing Jin, MD

CONTACT

+8613601365130jingjin1025@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chinese Academy of Medical Sciences and Peking Union Medical College

Study Record Dates

First Submitted

August 18, 2019

First Posted

August 20, 2019

Study Start

November 20, 2019

Primary Completion

September 21, 2022

Study Completion

September 21, 2023

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

CN(1)