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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03973008
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

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.

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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

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973008


Contacts
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Contact: Luying Liu 13957113195 luyingliu@163.com
Contact: Jinwen Shen 13616543578 shenjw2005@126.com

Locations
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China, Zhejiang
Jinwen Shen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jinwen Shen       shenjw2005@126.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Xiangdong Cheng Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03973008    
Other Study ID Numbers: ZJCH-GA-CRT
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhejiang Cancer Hospital:
Gastric Adenocarcinoma
Adjuvant Radiotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms