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

June 1, 2019 updated by: Zhejiang Cancer Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

408

Phase

  • 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 Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
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 Names:
  • 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 Names:
  • 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 Names:
  • CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: 3 year
after primary treatment the patient survives without any signs or symptoms of cancer.
3 year

Collaborators and Investigators

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

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Xiangdong Cheng, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 11, 2019

Primary Completion (Anticipated)

February 29, 2024

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

June 1, 2019

First Submitted That Met QC Criteria

June 1, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 1, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH-GA-CRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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