A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
17 september 2013 uppdaterad av: Wang Xin, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer.
Patients will be treated with external beam radiation therapy in a standard manner.
S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d.
Patients will be assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.
Studietyp
Interventionell
Inskrivning (Faktisk)
27
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Beijing, Kina, 100021
- Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing R0, R1, R2 resection, or with unresectable or locoregional recurrent disease
- 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:
- Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: S-1,peroral BID,capsule
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S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Andra namn:
S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Andra namn:
S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner
Andra namn:
S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Andra namn:
S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Andra namn:
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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To define dose limited toxicities(DLT) of S-1, peroral BID, in treatment days concurrently with radiation therapy (RT) in locally advanced or recurrent gastric cancer.
Tidsram: up to 9 weeks
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Dose limited toxicities defined as below: leucopenia ≥4 neutropenia ≥ 4, anemia ≥ 3, thrombocytopenia ≥ 3, alanine aminotransferase/aspartate aminotransferase (AST) ≥ 3, alkaline phosphatase (ALT) ≥ 3, total bilirubin ≥ 3,blood urea nitrogen (BUN)/Cr ≥ 2,non-granular cell decreased fever ≥ 2, nausea/vomiting ≥ 2, fatigue ≥ 3, weight loss ≥ 3, diarrhea ≥ 3, abdominal pain ≥ 3, dysphagia ≥ 3, hand-foot syndrome ≥ 2, neurotoxicity ≥ 2.
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up to 9 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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To define maximum tolerated dose(MTD) of S-1, peroral BID, in treatment days concurrently with radiation therapy
Tidsram: up to 9 weeks
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If 1 of 3 patients treated within a S-1 dose level experiences DLTs, 3 more patients will be treated at the same level.
If a second patient experiences DLTs, then escalation will be stopped and the MTD is defined as the level below DLT dose level.
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up to 9 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jing Jin, MD,PhD, Department of Radiation Oncology,Cancer Hospital and Institute,CAMS
- Huvudutredare: Yexiong Li, MD,PhD, Department of Radiation Oncology,Cancer Hospital and Institute, CAMS
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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. Erratum In: N Engl J Med. 2008 May 1;358(18):1977.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2010
Primärt slutförande (Faktisk)
1 augusti 2013
Avslutad studie (Faktisk)
1 september 2013
Studieregistreringsdatum
Först inskickad
7 februari 2011
Först inskickad som uppfyllde QC-kriterierna
7 februari 2011
Första postat (Uppskatta)
8 februari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 september 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 september 2013
Senast verifierad
1 september 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CH-GI-012
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