- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322969
Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy
February 23, 2021 updated by: Peking Union Medical College Hospital
Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy Versus Receiving the Original Chemotherapy in Locally Advanced Gastric Cancer: a Randomized Controlled Study
For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of <50% as the criterion of treatment change.
Sixty patients will be enrolled to randomize into two groups:receiving modified chemotherapy and receiving the original chemotherapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of <50% as the criterion of treatment change.
Sixty patients will be enrolled to randomize into two groups:receiving modified chemotherapy and receiving the original chemotherapy.
Overall survival and disease-free survival will be observed between two groups.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiang Wang, Doctor
- Phone Number: 011-86-10-69151279
- Email: wangxiang5123@126.com
Study Contact Backup
- Name: Lin Zhao, Doctor
- Phone Number: 011-86-10-69151279
- Email: wz20010727@aliyun.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100032
- Recruiting
- Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Xiang Wang, Doctor
- Phone Number: 011-86-10-69151279
- Email: wangxiang5123@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;
- ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;
- age ≥18 years old;
- no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;
- gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;
- signed the informed consent form.
Exclusion Criteria:
- All do not reach the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: receiving modified chemotherapy
Paclitaxel/DDP
|
receiving the modified chemotherapy
Other Names:
|
Active Comparator: receiving the original chemotherapy
XELOX/SOX
|
receiving the original chemotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease free survival
Time Frame: 3 year
|
DFS between two arms
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Lin Zhao, Doctor, Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2017
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
February 26, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- NAC-GC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced Gastric Cancer
-
Astellas Pharma Global Development, Inc.AvailableMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma Cancer | Metastatic Gastric Adenocarcinoma CancerUnited States
-
Astellas Pharma Global Development, Inc.Active, not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaUnited States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Spain, Taiwan, United Kingdom
-
Astellas Pharma Global Development, Inc.Active, not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaUnited States, Korea, Republic of, China, Spain, Taiwan, Japan, Argentina, Canada, Croatia, Greece, Ireland, Malaysia, Netherlands, Portugal, Romania, Thailand, Turkey, United Kingdom
-
Huashan HospitalSeattle Integrative Cancer CenterUnknownMetastatic Gastric Cancer | Locally Advanced Gastric CancerChina, United States
-
Gruppo Italiano per lo studio dei Carcinomi dell...Regione LombardiaTerminatedMetastatic Gastric Cancer | Locally Advanced Unresectable Gastric CancerItaly
-
Fudan UniversityUnknownMetastatic Gastric Cancer | Locally Advanced Gastric AdenocarcinomaChina
-
Tianshu LiuCompletedLocally Advanced Gastric CancerChina
-
Cai KailinUnknownLocally Advanced Gastric CancerChina
-
Fujian Medical UniversityNot yet recruitingLocally Advanced Gastric CancerChina
-
Fujian Medical UniversityActive, not recruitingLocally Advanced Gastric CancerChina
Clinical Trials on Paclitaxel/DDP
-
Washington University School of MedicineCelgene CorporationActive, not recruitingHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Cancer of the Head and NeckUnited States
-
Washington University School of MedicineCelgene CorporationActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and Neck | Carcinoma, Squamous Cell of the Head and NeckUnited States
-
First People's Hospital of FoshanNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisCompletedIdiopathic Dilation of the BronchiFrance
-
Sun Yat-sen UniversityRecruiting
-
Sun Yat-sen UniversityCompletedEsophageal Squamous Cell CarcinomaChina
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Cancer Institute and Hospital, Chinese Academy...Akeso Pharmaceuticals, Inc.Not yet recruitingMetastatic Esophageal Squamous Cell Carcinoma | Unresectable Esophageal Squamous Cell Carcinoma | Locally Advanced Esophageal Squamous Cell Carcinoma
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Shalvata Mental Health CenterNot yet recruitingPlacebo | Treatment 1:Dialectical Behavior Therapy (DBT) | Treatment 2:Dynamic Deconstructive Psychotherapy (DDP)