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Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma

Primary Purpose

Gastric Adenocarcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adjuvant Chemoradiotherapy
Adjuvant Chemotherapy
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Gastric Adenocarcinoma, Adjuvant Radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Voluntary Participation and Written Signature of Informed Consent.
  • Age 18-70, gender unlimited.
  • Gross pathology confirmed that the tumor center was within 1 cm to 5 cm of the EGJ line. Histopathologically diagnosed as adenocarcinoma.
  • No neoadjuvant therapy.
  • Transabdominal standard D2 radical operation was performed and R0 resection was performed. Ascites cytology was negative.
  • The pathological stages were IIB, IIIA, IIIB and IIIC.
  • There was no intraperitoneal implantation and distant metastasis. CT should be routinely performed to evaluate the tumor bed before radiotherapy. Positron emission tomography (PET-CT) could be accepted to determine whether there was residual or distant metastasis.
  • Physical condition score ECOG 0-1.
  • No history of serious heart and lung diseases, abnormal hematological examination and immunodeficiency: hemoglobin (Hb) > 9 g/dL; white blood cell (WBC) > 3 x 109/L; neutrophil (ANC) > 1.5 x 109/L; platelet (Pt) > 100 x 109/L; bilirubin < 1.5 times the upper limit of normal value; glutathione transaminase (ALT) & alanine transaminase (AST) = 2.5 times the upper limit of normal value; serum creatinine < 1.5 times the normal value Upper limit.
  • No other systemic tumors were found.
  • Fertile men or women are willing to take contraceptive measures in the trial.
  • The daily energy intake is more than 1500 kcal.

Exclusion Criteria:

  • Those who had a history of malignant tumors (except skin basal cell carcinoma, thyroid papillary adenocarcinoma and cervical carcinoma in situ, who survived for more than 3 years after treatment).
  • Patients with a history of neoadjuvant radiotherapy and chemotherapy before operation.
  • Study participants who participated in other clinical trials within 30 days before treatment.
  • Pregnancy, lactation or fertility without contraceptive measures.
  • Drug addiction and other adverse drug addiction, long-term alcoholism and AIDS patients.
  • Those with uncontrollable infections, seizures, or loss of self-awareness due to mental illness.
  • Those with a history of severe allergy or specific constitution.
  • Researchers believe that it is not appropriate to participate in this experiment.

Sites / Locations

  • Jinwen ShenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adujvant CT+CRT

Adujvant CT

Arm Description

Four to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy. And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.

The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.

Outcomes

Primary Outcome Measures

disease-free survival
after primary treatment the patient survives without any signs or symptoms of cancer.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2019
Last Updated
June 1, 2019
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03973008
Brief Title
Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
Official Title
Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard D2 radical resection.
Detailed Description
Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation. As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
Gastric Adenocarcinoma, Adjuvant Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adujvant CT+CRT
Arm Type
Experimental
Arm Description
Four to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy. And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.
Arm Title
Adujvant CT
Arm Type
Active Comparator
Arm Description
The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.
Intervention Type
Radiation
Intervention Name(s)
Adjuvant Chemoradiotherapy
Other Intervention Name(s)
CRT
Intervention Description
DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
Intervention Type
Drug
Intervention Name(s)
Adjuvant Chemotherapy
Other Intervention Name(s)
CT
Intervention Description
Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
Primary Outcome Measure Information:
Title
disease-free survival
Description
after primary treatment the patient survives without any signs or symptoms of cancer.
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary Participation and Written Signature of Informed Consent. Age 18-70, gender unlimited. Gross pathology confirmed that the tumor center was within 1 cm to 5 cm of the EGJ line. Histopathologically diagnosed as adenocarcinoma. No neoadjuvant therapy. Transabdominal standard D2 radical operation was performed and R0 resection was performed. Ascites cytology was negative. The pathological stages were IIB, IIIA, IIIB and IIIC. There was no intraperitoneal implantation and distant metastasis. CT should be routinely performed to evaluate the tumor bed before radiotherapy. Positron emission tomography (PET-CT) could be accepted to determine whether there was residual or distant metastasis. Physical condition score ECOG 0-1. No history of serious heart and lung diseases, abnormal hematological examination and immunodeficiency: hemoglobin (Hb) > 9 g/dL; white blood cell (WBC) > 3 x 109/L; neutrophil (ANC) > 1.5 x 109/L; platelet (Pt) > 100 x 109/L; bilirubin < 1.5 times the upper limit of normal value; glutathione transaminase (ALT) & alanine transaminase (AST) = 2.5 times the upper limit of normal value; serum creatinine < 1.5 times the normal value Upper limit. No other systemic tumors were found. Fertile men or women are willing to take contraceptive measures in the trial. The daily energy intake is more than 1500 kcal. Exclusion Criteria: Those who had a history of malignant tumors (except skin basal cell carcinoma, thyroid papillary adenocarcinoma and cervical carcinoma in situ, who survived for more than 3 years after treatment). Patients with a history of neoadjuvant radiotherapy and chemotherapy before operation. Study participants who participated in other clinical trials within 30 days before treatment. Pregnancy, lactation or fertility without contraceptive measures. Drug addiction and other adverse drug addiction, long-term alcoholism and AIDS patients. Those with uncontrollable infections, seizures, or loss of self-awareness due to mental illness. Those with a history of severe allergy or specific constitution. Researchers believe that it is not appropriate to participate in this experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luying Liu
Phone
13957113195
Email
luyingliu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jinwen Shen
Phone
13616543578
Email
shenjw2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangdong Cheng
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinwen Shen
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinwen Shen
Email
shenjw2005@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34717717
Citation
Shen J, Zhu X, Du Y, Zhu Y, Yu P, Yang L, Xu Z, Huang L, Zhang Y, Zhang Y, Liu L, Cheng X. Adjuvant SOX chemotherapy versus concurrent chemoradiotherapy after D2 radical resection of locally advanced esophagogastric junction (EGJ) adenocarcinoma: study protocol for a randomized phase III trial (ARTEG). Trials. 2021 Oct 30;22(1):753. doi: 10.1186/s13063-021-05617-7.
Results Reference
derived

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Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma

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