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.

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02736552
• Other study ID #: CGCG001
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: March 2023

Study information

• Verified date: May 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1 for 6 months
6 months S-1 after D2 resection
• S-1 for 1 year
1 year S-1 after D2 resection

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing	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	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Lishui hospital of Zhejiang University	Lishui	Zhejiang
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (11)

Lead Sponsor

Collaborator

Fudan University

Anhui Provincial Hospital, Anqing Municipal Hospital, First Affiliated Hospital of Wannan Medical College, Guangdong Provincial Hospital of Traditional Chinese Medicine, Lishui hospital of Zhejiang University, Shenzhen People's Hospital, Sun Yat-sen University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Yuebei People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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, Sirzén 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment expense	Total costs of treatment	12 months
Primary	Disease-free survival		3-year
Secondary	Overall survival		5-year
Secondary	Overall survival		3-year
Secondary	Side effects	Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder.	12 months

External Links

•   cancer
•   gastric cancer
•   S-1
•   stomach cancer
•   U.S. FDA Resources