Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

June 4, 2015 updated by: Jiafu Ji, Peking University

Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Haidian District, Beijing, China, 100142

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the gastroesophageal junction.
  • Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
  • Eastern Cooperative Oncology Group (ECOG) performance status≤2.
  • Informed consent obtained.

Exclusion Criteria:

  • Combined with other malignant tumors.
  • Eastern Cooperative Oncology Group (ECOG) performance status>2.
  • Combined with severe organ dysfunction.
  • Pregnancy

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CCRT group
The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
Radiation: Preoperative concurrent chemoradiotherapy
The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.
Other Names:
  • Eloxatin®
  • CCRT
  • S-1®
Procedure: Radical D2 total gastrectomy
Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.
Drug: Adjuvant chemotherapy
Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.
Other Names:
  • Eloxatin®
  • S-1®
Active Comparator: CT group
The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
Procedure: Radical D2 total gastrectomy
Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.
Drug: Adjuvant chemotherapy
Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.
Other Names:
  • Eloxatin®
  • S-1®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The patient's survival time and recurrence time
Time Frame: Up to 3 years

3-year overall survival

1-year and 3-year recurrence free survival
Up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of patients with complications
Time Frame: Within 30 days after the day of operation
the morbidity and mortality rates within 30 days after the day of operation
Within 30 days after the day of operation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The pathologic profiles and the pathologic response rates
Time Frame: Within 30 days after the day of operation
the pathologic profiles and the pathologic response rates
Within 30 days after the day of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University People's Hospital
Beijing Friendship Hospital
Chinese PLA General Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRADLE

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings