A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
NCT ID: NCT01291407
Last Updated: 2013-09-18
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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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2010-11-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S-1,peroral BID,capsule
S-1
S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner
S-1
S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Interventions
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S-1
S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner
S-1
S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
S-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any prior chemotherapy is allowed in this protocol.
* No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
* No prior abdominal or pelvic radiotherapy.
* Karnofsky performance status(KPS)≥ 70,predictive life span no less than 6 months
* Patients must have normal organ and marrow function as defined below:
* Leukocytes greater than or equal to 3,000 G/L
* Platelets: greater than or equal to 100,000/mm3
* Hemoglobin:greater than or equal to 10g/L
* Total bilirubin: within normal institutional limits
* AST/ALT: less than or equal to 1.5 times the upper limit
* Creatinine within normal upper limits
* Informed consent
* Without any serious complications,such as hypertension,coronary artery disease,psychiatric history.
Exclusion Criteria
* With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* History of prior radiation to the abdomen
* Pregnant or lactating females
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Wang Xin
Dr.
Principal Investigators
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Jing Jin, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology,Cancer Hospital and Institute,CAMS
Yexiong Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology,Cancer Hospital and Institute, CAMS
Locations
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Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, , China
Countries
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References
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Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999 Jan-Feb;49(1):33-64, 1. doi: 10.3322/canjclin.49.1.33.
Taguchi T, Inuyama Y, Kanamaru R, Hasegawa K, Akazawa S, Niitani H, Furue H, Kurihara M, Ota K, Suga S, Ariyoshi Y, Takai S, Shimoyama T, Toge T, Takashima S, Sugimachi K, Hara Y, Fujita H, Kimura K, Saito T, Tsukagoshi S, Nakao I. [Phase I study of S-1. S-1 Study Group]. Gan To Kagaku Ryoho. 1997 Dec;24(15):2253-64. Japanese.
van Groeningen CJ, Peters GJ, Schornagel JH, Gall H, Noordhuis P, de Vries MJ, Turner SL, Swart MS, Pinedo HM, Hanauske AR, Giaccone G. Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol. 2000 Jul;18(14):2772-9. doi: 10.1200/JCO.2000.18.14.2772.
Cohen SJ, Leichman CG, Yeslow G, Beard M, Proefrock A, Roedig B, Damle B, Letrent SP, DeCillis AP, Meropol NJ. Phase I and pharmacokinetic study of once daily oral administration of S-1 in patients with advanced cancer. Clin Cancer Res. 2002 Jul;8(7):2116-22.
Chu QS, Hammond LA, Schwartz G, Ochoa L, Rha SY, Denis L, Molpus K, Roedig B, Letrent SP, Damle B, DeCillis AP, Rowinsky EK. Phase I and pharmacokinetic study of the oral fluoropyrimidine S-1 on a once-daily-for-28-day schedule in patients with advanced malignancies. Clin Cancer Res. 2004 Aug 1;10(15):4913-21. doi: 10.1158/1078-0432.CCR-04-0469.
Takahashi I, Kakeji Y, Emi Y, Sakurai M, Yonemura Y, Kimura Y, Maehara Y. S-1 in the treatment of advanced and recurrent gastric cancer: current state and future prospects. Gastric Cancer. 2003;6 Suppl 1:28-33. doi: 10.1007/s10120-003-0228-5.
Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T. Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer. 1998 Oct;34(11):1715-20. doi: 10.1016/s0959-8049(98)00211-1.
Sugimachi K, Maehara Y, Horikoshi N, Shimada Y, Sakata Y, Mitachi Y, Taguchi T. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. The S-1 Gastrointestinal Cancer Study Group. Oncology. 1999 Oct;57(3):202-10. doi: 10.1159/000012032.
Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology. 2000 Apr;58(3):191-7. doi: 10.1159/000012099.
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. doi: 10.1056/NEJMoa072252.
Fujitani K, Tsujinaka T, Yamasaki H, Hirao M, Yoshida K, Kurokawa Y. Feasibility study of S-1 plus weekly docetaxel combined with concurrent radiotherapy in advanced gastric cancer refractory to first-line chemotherapy. Anticancer Res. 2009 Aug;29(8):3385-91.
Saikawa Y, Kubota T, Kumagai K, Nakamura R, Kumai K, Shigematsu N, Kubo A, Kitajima M, Kitagawa Y. Phase II study of chemoradiotherapy with S-1 and low-dose cisplatin for inoperable advanced gastric cancer. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):173-9. doi: 10.1016/j.ijrobp.2007.09.010. Epub 2007 Nov 8.
Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.
Other Identifiers
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CH-GI-012
Identifier Type: -
Identifier Source: org_study_id