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Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

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ClinicalTrials.gov Identifier: NCT02736552
Recruitment Status : Withdrawn
First Posted : April 13, 2016
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
Anhui Provincial Hospital
The First Affiliated Hospital of Anhui Medical University
Anqing Municipal Hospital
Yuebei People's Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shenzhen People's Hospital
First Affiliated Hospital of Wannan Medical College
Lishui hospital of Zhejiang University
Sun Yat-sen University
Information provided by (Responsible Party):
Dazhi Xu, Fudan University

Brief Summary:

The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 for 6 months Drug: S-1 for 1 year Phase 3

Detailed Description:

It has been identified that S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer(GC) in the Japanese Adjuvant Chemotherapy Trial of TS-1(S-1) for Gastric Cancer (ACTS-GC) trail , And S-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve equally or even more to overall survival(OS) and disease free survival(DFS) than S-1 for 1 year compared with S-1 for 6 months. As a result , An further clinical trail is still needed, This trial is designed to investigate the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

In this study, patients histologically confirmed stage II, IIIA or IIIB and who received D2 resection were randomly assigned to receive S-1 for 6 months or S-1 for 1 year. Patients aged from 18 to 75 years and adequate organ function, are randomized 1:1 to S-1 for 6 months and S-1 for 1 year. Both are the 3-week recycle of S-1 (80-120mg per day) for 2 weeks ,followed by 1 week of rest. The primary end point is 3-year DFS, and secondary end point is 5-year OS and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.In summary, we hold the hypothesis that S-1 for 6 months is equally effective, safer, and easier to carry out. If possible, there will be a new adjuvant chemotherapy strategy for gastric cancer patients after D2 resection.

To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The DATA and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: S-1 for 6 months
S-1 80-120mg daily for 14 days in 3 weeks for totally 6 months after D2 resection
Drug: S-1 for 6 months
6 months S-1 after D2 resection

Active Comparator: S-1 for 1 year
S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection
Drug: S-1 for 1 year
1 year S-1 after D2 resection




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5-year ]
  2. Overall survival [ Time Frame: 3-year ]
  3. Side effects [ Time Frame: 12 months ]
    Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder.


Other Outcome Measures:
  1. Treatment expense [ Time Frame: 12 months ]
    Total costs of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
  2. Be proven to be primary adenocarcinoma of gastric cancer and staged II,IIIA or IIIB by pathological evidences
  3. R0 surgery with lymphadenectomy
  4. Without any other malignancies
  5. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  6. No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram (WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L).

Exclusion Criteria:

  1. Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
  2. Patients with stage I, IIIC and IV.
  3. Unavailable for R0 resection and D2 lymph node dissection.
  4. Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
  5. With severe heart disease, including: congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension.
  6. Any Known or suspected history of drug allergy test.
  7. The researchers believe the patient is not able to complete the entire course of the experiment.
  8. Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
  9. Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.

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): NCT02736552


Locations
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China, Anhui
Anqing Municipal Hospital
Anqing, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
China, Guangdong
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Yuebei People's Hospital
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
China, Zhejiang
Lishui hospital of Zhejiang University
Lishui, Zhejiang, China
Sponsors and Collaborators
Fudan University
Anhui Provincial Hospital
The First Affiliated Hospital of Anhui Medical University
Anqing Municipal Hospital
Yuebei People's Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shenzhen People's Hospital
First Affiliated Hospital of Wannan Medical College
Lishui hospital of Zhejiang University
Sun Yat-sen University

Additional Information:
Publications:

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Responsible Party: Dazhi Xu, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02736552     History of Changes
Other Study ID Numbers: CGCG001
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Keywords provided by Dazhi Xu, Fudan University:
Gastric cancer
Adjuvant chemotherapy
S-1
D2 resection
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases