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

Primary Purpose

Gastroesophageal Junction Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Preoperative concurrent chemoradiotherapy

Radical D2 total gastrectomy

Adjuvant chemotherapy

About this trial

This is an interventional treatment trial for Gastroesophageal Junction Adenocarcinoma focused on measuring Preoperative concurrent chemoradiotherapy, Neoadjuvant chemoradiotherapy, Gastroesophageal junction adenocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CCRT group

CT group

Arm Description

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.

The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.

Outcomes

Primary Outcome Measures

The patient's survival time and recurrence time

3-year overall survival 1-year and 3-year recurrence free survival

Secondary Outcome Measures

The number of patients with complications

the morbidity and mortality rates within 30 days after the day of operation

Full Information

NCT ID

NCT02193594

First Posted

July 8, 2014

Last Updated

June 4, 2015

Sponsor

Peking University

Collaborators

Chinese PLA General Hospital, Peking University People's Hospital, Beijing Friendship Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02193594

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

Collaborators

Chinese PLA General Hospital, Peking University People's Hospital, Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Junction Adenocarcinoma

Keywords

Preoperative concurrent chemoradiotherapy, Neoadjuvant chemoradiotherapy, Gastroesophageal junction adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CCRT group

Arm Type

Experimental

Arm Description

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.

Arm Title

CT group

Arm Type

Active Comparator

Arm Description

The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.

Intervention Type

Radiation

Intervention Name(s)

Preoperative concurrent chemoradiotherapy

Other Intervention Name(s)

CCRT, Eloxatin®, S-1®

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Radical D2 total gastrectomy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Adjuvant chemotherapy

Other Intervention Name(s)

Eloxatin®, S-1®

Intervention Description

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.

Primary Outcome Measure Information:

Title

The patient's survival time and recurrence time

Description

3-year overall survival 1-year and 3-year recurrence free survival

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

The number of patients with complications

Description

the morbidity and mortality rates within 30 days after the day of operation

Time Frame

Within 30 days after the day of operation

Other Pre-specified Outcome Measures:

Title

The pathologic profiles and the pathologic response rates

Description

the pathologic profiles and the pathologic response rates

Time Frame

Within 30 days after the day of operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiafu Ji, M.D.

jiafuj@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiafu Ji, M.D.

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Haidian District

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuangxi Li, M.D.

lishuangxi@outlook.com

First Name & Middle Initial & Last Name & Degree

Jiafu Ji, M.D.

First Name & Middle Initial & Last Name & Degree

Ziyu Li, M.D.

First Name & Middle Initial & Last Name & Degree

Shuangxi Li, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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