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出境医 / 临床实验 / Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma

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

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.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Radiation: Adjuvant Chemoradiotherapy Drug: Adjuvant Chemotherapy Phase 3

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : May 31, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Adujvant CT+CRT
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.
Radiation: Adjuvant Chemoradiotherapy
DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
Other Name: CRT

Drug: Adjuvant Chemotherapy
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
Other Name: CT

Active Comparator: Adujvant CT
The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.
Drug: Adjuvant Chemotherapy
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
Other Name: CT

Outcome Measures
Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 year ]
    after primary treatment the patient survives without any signs or symptoms of cancer.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Luying Liu 13957113195 luyingliu@163.com
Contact: Jinwen Shen 13616543578 shenjw2005@126.com

Locations
Layout table for location information
China, Zhejiang
Jinwen Shen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jinwen Shen       shenjw2005@126.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Layout table for investigator information
Principal Investigator: Xiangdong Cheng Zhejiang Cancer Hospital
Tracking Information
First Submitted Date  ICMJE June 1, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE March 11, 2019
Estimated Primary Completion Date February 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2019)
disease-free survival [ Time Frame: 3 year ]
after primary treatment the patient survives without any signs or symptoms of cancer.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Adenocarcinoma
Intervention  ICMJE
  • Radiation: Adjuvant Chemoradiotherapy
    DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
    Other Name: CRT
  • Drug: Adjuvant Chemotherapy
    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
    Other Name: CT
Study Arms  ICMJE
  • Experimental: Adujvant CT+CRT
    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.
    Interventions:
    • Radiation: Adjuvant Chemoradiotherapy
    • Drug: Adjuvant Chemotherapy
  • Active Comparator: Adujvant CT
    The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.
    Intervention: Drug: Adjuvant Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2019)
408
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2025
Estimated Primary Completion Date February 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luying Liu 13957113195 luyingliu@163.com
Contact: Jinwen Shen 13616543578 shenjw2005@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973008
Other Study ID Numbers  ICMJE ZJCH-GA-CRT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiangdong Cheng Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP