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出境医 / 临床实验 / Enriched-CRT 2017: Advanced Gastric Cancer With LN+ and LVI+, Chemotherapy vs. Chemoradiotherapy

Enriched-CRT 2017: Advanced Gastric Cancer With LN+ and LVI+, Chemotherapy vs. Chemoradiotherapy

Study Description
Brief Summary:
This Enriched-CRT 2017 trial is a prospective, multicenter trial for adjuvant chemoradiotherapy (CRT) and chemotherapy (CT) in radical resected advanced gastric cancer (GC) patients with lymph node metastasis (LN+) and lymphovascular Invasion (LVI+). The primary purpose of this study is to evaluate the 3-year overall survival (OS) of enrolled patients receiving adjuvant chemoradiotherapy compared with those receiving adjuvant chemotherapy. The second purpose is to evaluate 3-year disease free survival (DFS) and determine the safety of CRT compared with CT in the patients enrolled in this study.

Condition or disease Intervention/treatment Phase
Gastric Cancer Radiation: chemoradiotherapy Drug: chemotherapy Phase 3

Detailed Description:

Gastric cancer is an important health problem, being the fourth most common cancer and the third leading cause of cancer-related death worldwide. Age standardized mortality rates for gastric cancer are 14.3 per 100 000 in men and 6.9 per 100 000 in women. More than 679 000 new cases and 498,000 deaths occur every year in China.

Local recurrence is considered as the most common way of recurrence for advanced gastric cancer, as well as an important factor for poor prognosis. Radiotherapy is a widely used technique in Western countries, and has been identified to have a significant role in decreasing local recurrence rate in breast cancer, and colon rectal cancer. At this moment, several randomized controlled trials have been conducted to identify the role of radiotherapy in advanced gastric cancer. Although the results from Europe (INT-0116), Dutch (CRITICS), and Korea (ARTIST) did not find that radiotherapy could improve the overall survival of enrolled patients, the sub-group analyses demonstrated that radiotherapy could improve the disease-free survival in patients with lymph node metastasis. We also found that adjuvant chemoradiotherapy could improve the survival of patients with lymph node metastasis or lymphovascular Invasion based on a large cohort study from National Cancer Database.

Therefore, our hypothesis is that advanced gastric cancer patients with lymph node metastasis or lymphovascular invasion are the group entity that could benefit from radiotherapy. At present, a new clinical trial (ARTIST II), aiming at advanced gastric cancer with positive lymph node metastasis, has been launched. China is one of the countries with the highest incidence of gastric cancer, sand nearly 80% of patients are diagnosed with advanced stage. So it's necessary to conduct the clinical research on this issue.

This Enriched-CRT 2017 trial is a prospective, multicenter trial for adjuvant chemoradiotherapy (CRT) and chemotherapy (CT) in radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion. The primary purpose of this study is to evaluate the 3-year overall survival (OS), and the second purpose is to evaluate 3-year disease free survival (DFS) and determine the safety of CRT compared with CT in the patients enrolled in this study.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Multicenter Randomized Controlled Trial of Adjuvant Chemoradiotherapy vs Chemotherapy for Radical Resected Advanced Gastric Carcinoma Concurrent With Lymph Node Metastasis and Lymphovascular Invasion
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Adjuvant chemoradiotherapy group
Adjuvant chemoradiotherapy (1 cycle CT: Oxaliplatin plus capecitabine (Xelox) or S-1 plus oxaliplatin (SOX), Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.
 Radiation: chemoradiotherapy
CRT (1 cycle CT: Xelox or SOX, Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.
Other Name: Study group (CRT)
Active Comparator: Adjuvant chemotherapy group
Adjuvant chemotherapy (6 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.
 Drug: chemotherapy
CT (6 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.
Other Name: Control group (CT)
Outcome Measures
Primary Outcome Measures :
  1. 3-year Overall Survival [ Time Frame: 3-year ]
    3-year Overall survival (OS) was defined as the time from the date of enrollment to the date of death or last visit.


Secondary Outcome Measures :
  1. 3-year Disease Free Survival [ Time Frame: 3-year ]
    3-year Disease Free Survival (DFS) was defined as time from the date of enrollment to the date of recurrence or last visit.

  2. Adverse effect (Safety and Tolerability) [ Time Frame: 30 days ]
    The evaluation of adverse effect is based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0


Eligibility Criteria
Layout table for eligibility information
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. Aged 18-75 years；
  • 2. Primary lesion is pathologically diagnosed as gastric adenocarcinoma (including Esophagogastric Junction adenocarcinoma), such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
  • 3. Received radical resection: R0 gastrectomy with D1/D2 lymphadenectomy (at least 15 lymph nodes were examined);
  • 4. Pathological stage pT2-4aN1-3M0 (According to American Joint Committee on Cancer (AJCC)-7th Tumor-Node-Metastasis (TNM) staging system), and with lymphovascular invasion, (LVI+);
  • 5. No evidence of distant metastases was observed by perioperative imaging;
  • 6. Postoperative performance status (ECOG, Eastern Cooperative Oncology Group) of 0-2;
  • 7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
  • 8. Adequate hematological function: Hemoglobin (Hb) ≥100g/L, Neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLC) ≥100×109/L;
  • 9. Adequate liver function: ALT、AST ≤2.5x upper limit of normal (ULN), Alkaline phosphatase (ALP) ≤2.5x ULN, Serum total bilirubin (TBIL) <1.5x ULN, Serum albumin(Alb) ≥30g/L;
  • 10. Adequate renal function: Serum creatinine ≤1.5mg/dl;
  • 11. Be able of oral feeding;
  • 12. Written informed consent.

Exclusion Criteria:

  • 1. Synchronous or metachronous (within 5 years) malignancies;
  • 2. Body temperature ≥ 38℃ or infectious disease with a systemic therapy indicated;
  • 3. Severe neurological or mental disease, including seizures or dementia, which may interfere compliance and sign of consent inform.
  • 4. Severe heart disease, including unstable angina pectoris, New York Heart Association (NYHA) class II or more advanced heart failure, severe arrhythmia despite medicinal treatment, or history of myocardial infarction within 12 months;
  • 5. Severe respiratory disease;
  • 6. Moderate or severe renal dysfunction: Creatinine clearance rate (CCR) ≤50 ml/min, or Serum creatinine >ULN ;
  • 7. Upper gastrointestinal tract obstruction, physiological dysfunction, or malabsorption syndrome, which affect the absorption of oral drugs;
  • 8. Peripheral nervous disease (NCI CTC version> 1.0 grade), except for patients with ony disappeared deep tendinous reflect (DTR);
  • 9. Women during pregnancy or breast-feeding;
  • 10. Fertile women with a positive pregnancy test, or no pregnancy test; postmenopausal within 12 months;
  • 11. Fertile men or women who refuse to use contraception during the study period;
  • 12. Patients are participating or have participated in another clinical trial (within 6 months);
  • 13. Continuous systemic steroid therapy within 1 month (except for topical use), or received organ transplantation that needs immunosuppressive agent;
  • 14. Dihydropyrimidine dehydrogenase (DPD) deficiency;
  • 15. Allergy to platinum compound, or any component of drugs used in the study.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xuefei Wang, MD, PhD 86-13917270428 wang.xuefei@zs-hospital.sh.cn

Locations
Layout table for location information
China, Shanghai
ZhongShan hospital FuDan university
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Layout table for investigator information
Principal Investigator: Xuefei Wang, MD, PhD Fudan University
Tracking Information
First Submitted Date  ICMJE September 19, 2018
First Posted Date  ICMJE September 21, 2018
Last Update Posted Date September 21, 2018
Estimated Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2018) 		3-year Overall Survival [ Time Frame: 3-year ]
3-year Overall survival (OS) was defined as the time from the date of enrollment to the date of death or last visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2018)
  • 3-year Disease Free Survival [ Time Frame: 3-year ]
    3-year Disease Free Survival (DFS) was defined as time from the date of enrollment to the date of recurrence or last visit.
  • Adverse effect (Safety and Tolerability) [ Time Frame: 30 days ]
    The evaluation of adverse effect is based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enriched-CRT 2017: Advanced Gastric Cancer With LN+ and LVI+, Chemotherapy vs. Chemoradiotherapy
Official Title  ICMJE Phase III Multicenter Randomized Controlled Trial of Adjuvant Chemoradiotherapy vs Chemotherapy for Radical Resected Advanced Gastric Carcinoma Concurrent With Lymph Node Metastasis and Lymphovascular Invasion
Brief Summary This Enriched-CRT 2017 trial is a prospective, multicenter trial for adjuvant chemoradiotherapy (CRT) and chemotherapy (CT) in radical resected advanced gastric cancer (GC) patients with lymph node metastasis (LN+) and lymphovascular Invasion (LVI+). The primary purpose of this study is to evaluate the 3-year overall survival (OS) of enrolled patients receiving adjuvant chemoradiotherapy compared with those receiving adjuvant chemotherapy. The second purpose is to evaluate 3-year disease free survival (DFS) and determine the safety of CRT compared with CT in the patients enrolled in this study.
Detailed Description

Gastric cancer is an important health problem, being the fourth most common cancer and the third leading cause of cancer-related death worldwide. Age standardized mortality rates for gastric cancer are 14.3 per 100 000 in men and 6.9 per 100 000 in women. More than 679 000 new cases and 498,000 deaths occur every year in China.

Local recurrence is considered as the most common way of recurrence for advanced gastric cancer, as well as an important factor for poor prognosis. Radiotherapy is a widely used technique in Western countries, and has been identified to have a significant role in decreasing local recurrence rate in breast cancer, and colon rectal cancer. At this moment, several randomized controlled trials have been conducted to identify the role of radiotherapy in advanced gastric cancer. Although the results from Europe (INT-0116), Dutch (CRITICS), and Korea (ARTIST) did not find that radiotherapy could improve the overall survival of enrolled patients, the sub-group analyses demonstrated that radiotherapy could improve the disease-free survival in patients with lymph node metastasis. We also found that adjuvant chemoradiotherapy could improve the survival of patients with lymph node metastasis or lymphovascular Invasion based on a large cohort study from National Cancer Database.

Therefore, our hypothesis is that advanced gastric cancer patients with lymph node metastasis or lymphovascular invasion are the group entity that could benefit from radiotherapy. At present, a new clinical trial (ARTIST II), aiming at advanced gastric cancer with positive lymph node metastasis, has been launched. China is one of the countries with the highest incidence of gastric cancer, sand nearly 80% of patients are diagnosed with advanced stage. So it's necessary to conduct the clinical research on this issue.

This Enriched-CRT 2017 trial is a prospective, multicenter trial for adjuvant chemoradiotherapy (CRT) and chemotherapy (CT) in radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion. The primary purpose of this study is to evaluate the 3-year overall survival (OS), and the second purpose is to evaluate 3-year disease free survival (DFS) and determine the safety of CRT compared with CT in the patients enrolled in this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Radiation: chemoradiotherapy
    CRT (1 cycle CT: Xelox or SOX, Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.
    Other Name: Study group (CRT)
  • Drug: chemotherapy
    CT (6 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.
    Other Name: Control group (CT)
Study Arms  ICMJE
  • Experimental: Adjuvant chemoradiotherapy group
    Adjuvant chemoradiotherapy (1 cycle CT: Oxaliplatin plus capecitabine (Xelox) or S-1 plus oxaliplatin (SOX), Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.
    Intervention: Radiation: chemoradiotherapy
  • Active Comparator: Adjuvant chemotherapy group
    Adjuvant chemotherapy (6 cycles CT: Xelox or SOX, Q21d×3) for patients enrolled in this group.
    Intervention: Drug: chemotherapy
Publications *
  • Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30.
  • Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20.
  • Smalley SR, Benedetti JK, Haller DG, Hundahl SA, Estes NC, Ajani JA, Gunderson LL, Goldman B, Martenson JA, Jessup JM, Stemmermann GN, Blanke CD, Macdonald JS. Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection. J Clin Oncol. 2012 Jul 1;30(19):2327-33. doi: 10.1200/JCO.2011.36.7136. Epub 2012 May 14.
  • Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. Erratum in: N Engl J Med. 2008 May 1;358(18):1977.
  • Ashraf N, Hoffe S, Kim R. Adjuvant treatment for gastric cancer: chemotherapy versus radiation. Oncologist. 2013;18(9):1013-21. doi: 10.1634/theoncologist.2012-0462. Epub 2013 Aug 21. Review.
  • Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, Lim HY, Choi MG, Sohn TS, Noh JH, Bae JM, Ahn YC, Sohn I, Jung SH, Park CK, Kim KM, Kang WK. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012 Jan 20;30(3):268-73. doi: 10.1200/JCO.2011.39.1953. Epub 2011 Dec 19.
  • Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5.
  • Mamon HJ, Tepper JE. Combination chemoradiation therapy: the whole is more than the sum of the parts. J Clin Oncol. 2014 Feb 10;32(5):367-9. doi: 10.1200/JCO.2013.54.3108. Epub 2014 Jan 13.
  • Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.
  • Wolmark N, Wieand HS, Hyams DM, Colangelo L, Dimitrov NV, Romond EH, Wexler M, Prager D, Cruz AB Jr, Gordon PH, Petrelli NJ, Deutsch M, Mamounas E, Wickerham DL, Fisher ER, Rockette H, Fisher B. Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02. J Natl Cancer Inst. 2000 Mar 1;92(5):388-96.
  • D'Angelica M, Gonen M, Brennan MF, Turnbull AD, Bains M, Karpeh MS. Patterns of initial recurrence in completely resected gastric adenocarcinoma. Ann Surg. 2004 Nov;240(5):808-16.
  • 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.
  • Noh SH, Park SR, Yang HK, Chung HC, Chung IJ, Kim SW, Kim HH, Choi JH, Kim HK, Yu W, Lee JI, Shin DB, Ji J, Chen JS, Lim Y, Ha S, Bang YJ; CLASSIC trial investigators. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1389-96. doi: 10.1016/S1470-2045(14)70473-5. Epub 2014 Oct 15.
  • Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.
  • Li P, He HQ, Zhu CM, Ling YH, Hu WM, Zhang XK, Luo RZ, Yun JP, Xie D, Li YF, Cai MY. The prognostic significance of lymphovascular invasion in patients with resectable gastric cancer: a large retrospective study from Southern China. BMC Cancer. 2015 May 7;15:370. doi: 10.1186/s12885-015-1370-2.
  • Dicken BJ, Graham K, Hamilton SM, Andrews S, Lai R, Listgarten J, Jhangri GS, Saunders LD, Damaraju S, Cass C. Lymphovascular invasion is associated with poor survival in gastric cancer: an application of gene-expression and tissue array techniques. Ann Surg. 2006 Jan;243(1):64-73.
  • Lee JH, Kim MG, Jung MS, Kwon SJ. Prognostic significance of lymphovascular invasion in node-negative gastric cancer. World J Surg. 2015 Mar;39(3):732-9. doi: 10.1007/s00268-014-2846-y.
  • Dikken JL, van Sandick JW, Maurits Swellengrebel HA, Lind PA, Putter H, Jansen EP, Boot H, van Grieken NC, van de Velde CJ, Verheij M, Cats A. Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS). BMC Cancer. 2011 Aug 2;11:329. doi: 10.1186/1471-2407-11-329.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018) 		556
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Aged 18-75 years；
  • 2. Primary lesion is pathologically diagnosed as gastric adenocarcinoma (including Esophagogastric Junction adenocarcinoma), such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
  • 3. Received radical resection: R0 gastrectomy with D1/D2 lymphadenectomy (at least 15 lymph nodes were examined);
  • 4. Pathological stage pT2-4aN1-3M0 (According to American Joint Committee on Cancer (AJCC)-7th Tumor-Node-Metastasis (TNM) staging system), and with lymphovascular invasion, (LVI+);
  • 5. No evidence of distant metastases was observed by perioperative imaging;
  • 6. Postoperative performance status (ECOG, Eastern Cooperative Oncology Group) of 0-2;
  • 7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
  • 8. Adequate hematological function: Hemoglobin (Hb) ≥100g/L, Neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLC) ≥100×109/L;
  • 9. Adequate liver function: ALT、AST ≤2.5x upper limit of normal (ULN), Alkaline phosphatase (ALP) ≤2.5x ULN, Serum total bilirubin (TBIL) <1.5x ULN, Serum albumin(Alb) ≥30g/L;
  • 10. Adequate renal function: Serum creatinine ≤1.5mg/dl;
  • 11. Be able of oral feeding;
  • 12. Written informed consent.

Exclusion Criteria:

  • 1. Synchronous or metachronous (within 5 years) malignancies;
  • 2. Body temperature ≥ 38℃ or infectious disease with a systemic therapy indicated;
  • 3. Severe neurological or mental disease, including seizures or dementia, which may interfere compliance and sign of consent inform.
  • 4. Severe heart disease, including unstable angina pectoris, New York Heart Association (NYHA) class II or more advanced heart failure, severe arrhythmia despite medicinal treatment, or history of myocardial infarction within 12 months;
  • 5. Severe respiratory disease;
  • 6. Moderate or severe renal dysfunction: Creatinine clearance rate (CCR) ≤50 ml/min, or Serum creatinine >ULN ;
  • 7. Upper gastrointestinal tract obstruction, physiological dysfunction, or malabsorption syndrome, which affect the absorption of oral drugs;
  • 8. Peripheral nervous disease (NCI CTC version> 1.0 grade), except for patients with ony disappeared deep tendinous reflect (DTR);
  • 9. Women during pregnancy or breast-feeding;
  • 10. Fertile women with a positive pregnancy test, or no pregnancy test; postmenopausal within 12 months;
  • 11. Fertile men or women who refuse to use contraception during the study period;
  • 12. Patients are participating or have participated in another clinical trial (within 6 months);
  • 13. Continuous systemic steroid therapy within 1 month (except for topical use), or received organ transplantation that needs immunosuppressive agent;
  • 14. Dihydropyrimidine dehydrogenase (DPD) deficiency;
  • 15. Allergy to platinum compound, or any component of drugs used in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xuefei Wang, MD, PhD 86-13917270428 wang.xuefei@zs-hospital.sh.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03680261
Other Study ID Numbers  ICMJE ZSGC-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xuefei.Wang, Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xuefei Wang, MD, PhD Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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