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.
NCT ID: NCT02736552
Last Updated: 2019-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-03-31
2023-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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S-1 for 6 months
S-1 80-120mg daily for 14 days in 3 weeks for totally 6 months after D2 resection
S-1 for 6 months
6 months S-1 after D2 resection
S-1 for 1 year
S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection
S-1 for 1 year
1 year S-1 after D2 resection
Interventions
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S-1 for 6 months
6 months S-1 after D2 resection
S-1 for 1 year
1 year S-1 after D2 resection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Anhui Provincial Hospital
OTHER_GOV
The First Affiliated Hospital of Anhui Medical University
OTHER
Anqing Municipal Hospital
OTHER
Yuebei People's Hospital
OTHER
The First Affiliated Hospital of Guangdong Pharmaceutical University
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Shenzhen People's Hospital
OTHER
First Affiliated Hospital of Wannan Medical College
OTHER
Lishui hospital of Zhejiang University
UNKNOWN
Sun Yat-sen University
OTHER
Responsible Party
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Dazhi Xu
Professor
Locations
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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
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
Lishui hospital of Zhejiang University
Lishui, Zhejiang, China
Countries
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References
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Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.
Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
Tsuburaya A, Yoshida K, Kobayashi M, Yoshino S, Takahashi M, Takiguchi N, Tanabe K, Takahashi N, Imamura H, Tatsumoto N, Hara A, Nishikawa K, Fukushima R, Nozaki I, Kojima H, Miyashita Y, Oba K, Buyse M, Morita S, Sakamoto J. Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trial. Lancet Oncol. 2014 Jul;15(8):886-93. doi: 10.1016/S1470-2045(14)70025-7. Epub 2014 Jun 18.
O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons RJ Jr, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol. 1998 Jan;16(1):295-300. doi: 10.1200/JCO.1998.16.1.295.
Chen S, Chen YB, Zhou ZW, Li W, Sun XW, Xu DZ, Li YF, Guan YX, Feng XY, Zhan YQ. No survival benefit from postoperative adjuvant chemotherapy after D2 radical resection for the patients with stage II gastric cancer. Am J Clin Oncol. 2011 Jun;34(3):309-13. doi: 10.1097/COC.0b013e3181dea94e.
Ji J, Liang H, Zhan Y, Liu Y, He Y, Ye Y, Sun Y, Huang C, Yan M, Shi Y, Wu A. [Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): Chinese subgroup analysis]. Zhonghua Wei Chang Wai Ke Za Zhi. 2014 Feb;17(2):133-8. Chinese.
Qu JL, Li X, Qu XJ, Zhu ZT, Zhou LZ, Teng YE, Zhang JD, Jin B, Zhao MF, Yu P, Liu YP. Optimal duration of fluorouracil-based adjuvant chemotherapy for patients with resectable gastric cancer. PLoS One. 2013 Dec 26;8(12):e83196. doi: 10.1371/journal.pone.0083196. eCollection 2013.
Related Links
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stomach cancer
U.S. FDA Resources
Other Identifiers
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CGCG001
Identifier Type: -
Identifier Source: org_study_id
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