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Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer

12. juni 2013 opdateret af: Young Suk Park, Samsung Medical Center

A Randomized Phase III Study of SOX vs. COX in Patients With Advanced Colorectal Cancer

Primary objective :

To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma.

Secondary objectives :

  1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
  2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • The urgent need for new effective therapy with better safety profile for metastatic colorectal cancer patients and promising results observed so far in trials with S-1 combined with oxaliplatin in gastrointestinal cancer including colorectal cancer strongly warrants the comparison of S-1 combined with oxaliplatin to capecitabine combination with oxaliplatin acknowledged as a standard regimen in a first-line treatment for advanced colorectal cancer patients.
  • Recently, a Phase I study was completed, indicating recommended dose as S-1 100 mg/m2/day1-14 and oxaliplatin (130 mg/m2/day1), repeated every 3 weeks. However, in the phase II study using the above recommended dose, delayed toxicities of thrombocytopenia and anemia were observed. These delayed toxicities were also reported in a phase II study using S-1 90 mg/m2/day plus oxaliplatin 130 mg/m2/day1 in advanced gastric cancer. At 2007 GI ASCO, the interim data of S-1(80 mg/m2/day1-14) plus oxaliplatin (130 mg/m2/day1) combination, repeated every 3 weeks, was presented, showing promising antitumor activity with favourable safety profile. Among 18 patients, there were only two patients with Grade 3 thrombocytopenia and one with Grade 3 neutropenia. Response rate was 57.1 % and disease control rate was 92.9 %. Considering these results and Japanese data which showed that enhanced efficacy was not observed with S-1 over 90 mg/m2/day and oxaliplatin combination, S-1 80 mg/m2/day 1-14 and oxaliplatin 130 mg/m2/D1, repeated every 3 weeks, will be tested in this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

344

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Daegu, Korea, Republikken, 705-717
        • Yeungnam university
      • Inchon, Korea, Republikken
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republikken
        • Seoul National University Hospital
      • Seoul, Korea, Republikken, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republikken, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republikken
        • Yonsei University
      • Seoul, Korea, Republikken, 139-706
        • Korea Cancer Center Hospital
      • Seoul, Korea, Republikken, 140-743
        • Soon Chun Hyang University Hospital
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republikken, 410-769
        • National Cancer Center
      • Seongnam, Gyeonggi, Korea, Republikken
        • Seoul National University Bundang Hospital
    • Jeollanamdo
      • Hwasun, Jeollanamdo, Korea, Republikken, 519-809
        • Chonnam National University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically documented colorectal adenocarcinoma
  • Age over 18 years old
  • Performance status (ECOG scale): 0-2
  • Measurable or evaluable disease
  • Patients can take food and drugs orally
  • Adequate organ functions
  • Life expectancy ≥ 3 months
  • Patients should sign a written informed consent before study entry

Exclusion Criteria:

  • Tumor type other than adenocarcinoma
  • Second primary malignancy
  • Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer
  • Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
  • Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization.
  • Presence of CNS metastasis
  • Obvious peritoneal seeding or bowel obstruction disturbing oral intake
  • Symptomatic peripheral neuropathy
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. The patient received curative operation or RFA for metastatic disease.
  • Serious illness or medical conditions
  • Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent phenytoin warfarin etc.
  • Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
  • Pregnant or lactating woman
  • Women of child bearing potential not using a contraceptive method
  • Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
  • Any patients judged by the investigator to be unfit to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: S-1 and Oxaliplatin

S-1 and Oxaliplatin

S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks
Medicin: S-1 & Oxaliplatin
S-1 and Oxaliplatin : S-1 80 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Andre navne:
  • S-1 and Oxaliplatin
Aktiv komparator: Capecitabine and Oxaliplatin
Medicin: Capecitabine & Oxaliplatin
COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks
Andre navne:
  • Capecitabin og Oxaliplatin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma.
Tidsramme: 9 months
9 months

Sekundære resultatmål

Resultatmål
Tidsramme
To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
Tidsramme: 24 months
24 months
To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.
Tidsramme: 24 months
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samsung Medical Center

Samarbejdspartnere

National Cancer Center, Korea
Asan Medical Center
Chonnam National University Hospital
Seoul National University Hospital
Seoul National University Bundang Hospital
Yonsei University
Gachon University Gil Medical Center

Efterforskere

  • Studiestol: Young Suk Park, M.D.,Ph.D., Samsung medical center, Seoul, Korea
  • Ledende efterforsker: Hye Jin Kang, M.D.,Ph.D., Korea Cancer Center Hospital , Seoul, Korea
  • Ledende efterforsker: Jee Hyun Kim, M.D.,Ph.D., Seoul National University Bundang Hospital, Gyeonggi, Korea
  • Ledende efterforsker: Tae Won Kim, M.D.,Ph.D., Asan medical center, Seoul, Korea
  • Ledende efterforsker: Tae-Yoo Kim, M.D.,Ph.D., Seoul National University Hospital , Seoul, Korea
  • Ledende efterforsker: Dong Bok Shin, M.D.,Ph.D., Gil Medical Center, Gyeonggi, Korea
  • Ledende efterforsker: Joong Bae Ahn, M.D.,Ph.D., Yonsei Medical Center, Severance Hospital, Seoul, Korea
  • Ledende efterforsker: Kyung Hee Lee, M.D.,Ph.D., Yeungnam University College of Medicine , Daegu, Korea
  • Ledende efterforsker: Namsu Lee, M.D.,Ph.D., Soon Chun Hyang University Hospital , Seoul, Korea
  • Ledende efterforsker: Ik-Joo Chung, M.D.,Ph.D., Chonnam National University Hwasun Hospital, Jeollanamdo, Korea
  • Ledende efterforsker: Yong Sang Hong, M.D.,Ph.D., National Cancer Center, Gyeonggi, Korea

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2008

Primær færdiggørelse (Faktiske)

1. september 2009

Studieafslutning (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

12. maj 2008

Først indsendt, der opfyldte QC-kriterier

13. maj 2008

Først opslået (Skøn)

14. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2008-03-012

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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