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.

NCT02736552 | Withdrawn Phase 3 DMC

• 1 other identifier: CGCG001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Adjuvant chemotherapy; S-1; D2 resection

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  3-year

Secondary Outcomes (3)

• Overall survival

  5-year

• Overall survival

  3-year

• Side effects

  12 months

Other Outcomes (1)

• Treatment expense

  12 months

Study Arms (2)

S-1 for 6 months

EXPERIMENTAL

S-1 80-120mg daily for 14 days in 3 weeks for totally 6 months after D2 resection

Drug: S-1 for 6 months

S-1 for 1 year

ACTIVE COMPARATOR

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

Drug: S-1 for 1 year

Interventions

S-1 for 6 months DRUG

6 months S-1 after D2 resection

S-1 for 6 months

S-1 for 1 year DRUG

1 year S-1 after D2 resection

S-1 for 1 year

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
• Be proven to be primary adenocarcinoma of gastric cancer and staged II，IIIA or IIIB by pathological evidences
• R0 surgery with lymphadenectomy
• Without any other malignancies
• ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
• 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).

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (10)

Anqing Municipal Hospital

Anqing, Anhui, China

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Location

Yuebei People's Hospital

Guangzhou, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

Lishui hospital of Zhejiang University

Lishui, Zhejiang, China

Location

Related Publications (7)

• 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.

  PMID: 22010012 BACKGROUND

• 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.

  PMID: 22226517 BACKGROUND

• 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.

  PMID: 24954805 BACKGROUND

• 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.

  PMID: 9440756 BACKGROUND

• 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.

  PMID: 20838324 BACKGROUND

• 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.

  PMID: 24577767 BACKGROUND

• 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.

  PMID: 24386161 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2023
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

CN (10)