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A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Primary Purpose

Gastric Cancer, Neoadjuvant Therapy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SIB-IMRT
S-1
SOX
Surgery
Sponsored by
Jing Jin, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Total Neoadjuvant Chemoradiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Acute chemotherapy/Chemoradiotherapy toxicities
chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.
surgery complications
During hospital stay and within the first 30 days after completion of surgery.
Tumor down-staging
Down-staging was considered as any stage reduction between clinical and pathologic stage.
R0 resection rate
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after total neoadjuvant therapy.

Full Information

First Posted
August 18, 2019
Last Updated
January 20, 2022
Sponsor
Jing Jin, M.D.
Collaborators
Beijing Hope Run
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1. Study Identification

Unique Protocol Identification Number
NCT04062058
Brief Title
A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Official Title
A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
September 21, 2022 (Anticipated)
Study Completion Date
September 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Jin, M.D.
Collaborators
Beijing Hope Run

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Neoadjuvant Therapy
Keywords
gastric cancer, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total Neoadjuvant Chemoradiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
SIB-IMRT
Intervention Description
45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment
Intervention Type
Drug
Intervention Name(s)
SOX
Intervention Description
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery, preferred D2 lymphadenectomy
Primary Outcome Measure Information:
Title
PCR rate
Description
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).
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Acute chemotherapy/Chemoradiotherapy toxicities
Description
chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.
Time Frame
6-8 months
Title
surgery complications
Description
During hospital stay and within the first 30 days after completion of surgery.
Time Frame
6-8 months
Title
Tumor down-staging
Description
Down-staging was considered as any stage reduction between clinical and pathologic stage.
Time Frame
6-8 months
Title
R0 resection rate
Description
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after total neoadjuvant therapy.
Time Frame
6-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Jin, MD
Phone
+8613601365130
Email
jingjin1025@163.com
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
+8613810381399
Email
lee_ak@163.com
First Name & Middle Initial & Last Name & Degree
Jinming Shi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35902798
Citation
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.
Results Reference
derived
PubMed Identifier
35219300
Citation
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.
Results Reference
derived

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A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer

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