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Maintenance Treatment With S-1 in Gastric Cancer Patients

7. oktober 2018 oppdatert av: Ruihua Xu, Sun Yat-sen University

Maintenance Treatment With S-1 Versus Observation After First-line Chemotherapy in Patients With Advanced Gastric Cancer: a Randomized Phase II Study

Gastric cancer remains the third leading cause of cancer-related death worldwide and is especially frequent in East Asia. Fluoropyrimidines are the backbone of first-line chemotherapy for advanced gastric cancer (AGC), and S-1 provides new option with its simplicity and convenience.

5-Fluorouracil (5-FU) was the only efficacious treatment for AGC before the nineties of the 20th century, and afterwards with the discovery of chemotherapy such as cisplatin, oxaliplatin, S-1 and capecitabine, response rate as well as survival had been improved greatly.

Most of AGC will progress after first-line treatment; therefore, seeking an efficient and low toxic maintaining regimen to prolong progression-free survival (PFS) becomes a hot topic in oncologic field. Some clinical researches demonstrated maintenance treatment for advanced colorectal cancer (CRC) and lung cancer. The investigators had conducted a phase III clinical trial that demonstrated capecitabine maintenance versus observation prolonged PFS significantly after first-line chemotherapy with FOLFOX or XELOX regimens in advanced CRC. In AGC, several retrospective studies revealed patients receiving 5-FU/leucovorin(LV), capecitabine, or trastuzumab maintaining therapy experienced significantly longer PFS than that stopped chemotherapy after first-line chemotherapy. Some one-arm phase II clinical trials found 5-FU/LV, capecitabine, S-1, capecitabine plus bevacirumab, or capecitabine plus bevacirumab plus trastuzumab maintenance seemed to yield sound PFS and good tolerance. However, there were no randomized controlled clinical trials for maintenance treatment of these regimens in AGC, except that a phase II Chinese randomized controlled trial of Uracil and Tegafur (UFT) versus observation experienced early termination.

Above all, so far, there is no data to demonstrate that regular 2-6 months of chemotherapy followed by maintenance treatment could prolong PFS and OS for AGC. S-1 is effective for gastric cancer, and was approved as palliative treatment for advanced gastric cancer and adjuvant treatment; in addition, with its relative less frequency of side effects and convenient oral administration, S-1 as maintenance regimen could be prone to be accepted by patients. Therefore, the current study is designed to investigate that S-1 as maintenance treatment after first-line palliative chemotherapy could improve PFS and OS for patients with advanced gastric cancer through a perspective randomized clinical study.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients with AGC who achieved objective response or stable disease after 2-6 months of first-line chemotherapy were randomly assigned to one of two groups, to receive either S-1 (40 mg for BSA<1.25 m2, 50 mg for 1.25≤BSA<1.50 m2 and 60 mg for BSA≥1.50 m2 b.i.d. on days 1-14, q3w) as maintenance therapy or observation. The treatment will continue until disease progression or unacceptable toxicity.

Studietype

Intervensjonell

Registrering (Forventet)

200

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Rekruttering
        • Sun Yat-sen University Cancer Center
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age older than 18 years
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)
  • Histologically confirmed gastric cancer with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy
  • No previous chemotherapy for metastatic GC was allowed, the interval after the end of adjuvant/neoadjuvant chemotherapy beyond 6 months was allowable
  • Life expectancy of at least 3 months
  • Adequate hematologic, hepatic and renal function. Neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), AST or ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases), alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases); serum creatinine ≤ 1.5 × ULN；and albumin ≥ 25 g/L
  • Patients who achieved objective response or stable disease after 2-6 month first-line chemotherapy
  • The first-line chemotherapy regimens were doublets including platinum (cisplatin or oxaliplatin) plus fluoropyrimidine (5-FU, capecitabine, or S-1)
  • Signed informed consent

Exclusion Criteria:

  • Known hypersensitivity to platinum (cisplatin or oxaliplatin) or fluoropyrimidine (5-FU, capecitabine, or S-1)
  • History or clinical evidence of brain metastases
  • Previous chemotherapy for metastatic disease
  • Positive serum pregnancy test in women of childbearing potential
  • Subjects with reproductive potential not willing to use an effective method of contraception
  • Received any investigational drug treatment within 4 weeks of start of study treatment
  • Other prior malignancies in the past 5 years
  • Unresolved bowel obstruction or malabsorption syndrome

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: S-1 maintenance group
S-1 maintenance
Legemiddel: S-1 maintenance
S-1 maintenance till disease progression or untolerable toxicities, in oral doses of 40 mg (BSA<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 for each 21-day cycle.
Andre navn:
  • S-1 monotherapy maintenance
Annen: Observation group
Observation without anti-tumor treatment
Annen: Observation
Observation without anti-tumor treatment
Andre navn:
  • Observation without anti-tumor treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
maintenance progression-free survival (PFS)
Tidsramme: from date of randomization to maintenance or observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
The Kaplan-Meier survival from randomization to maintenance or observation until the date of first documented progression or date of death from any cause, whichever came first.
from date of randomization to maintenance or observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
progression-free survival from induction treatment (PFS2)
Tidsramme: from induction treatment (the initiation date of first-line chemotherapy) until the date of first documented progression or date of death from any cause after maintenance treatment or observation, whichever came first, assessed up to 2 years
The Kaplan-Meier survival from induction treatment (the initiation date of first-line chemotherapy) until the date of first documented progression or date of death from any cause after maintenance treatment or observation, whichever came first
from induction treatment (the initiation date of first-line chemotherapy) until the date of first documented progression or date of death from any cause after maintenance treatment or observation, whichever came first, assessed up to 2 years
overall survival (OS)
Tidsramme: from induction treatment (the initiation date of first-line chemotherapy) until death from any cause or the last follow-up date, assessed up to 2 years.
The Kaplan-Meier survival from induction treatment (the initiation date of first-line chemotherapy) until death from any cause or the last follow-up date.
from induction treatment (the initiation date of first-line chemotherapy) until death from any cause or the last follow-up date, assessed up to 2 years.
toxicity relevant to S-1 maintenance/observation
Tidsramme: from date of randomization to maintenance or observation until the date of first documented progression or unaccepted toxicities, assessed up to 30 days after the last oral administration of S-1.
any toxicities occurring during the treatment of S-1 maintenance/observation
from date of randomization to maintenance or observation until the date of first documented progression or unaccepted toxicities, assessed up to 30 days after the last oral administration of S-1.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sun Yat-sen University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2016

Primær fullføring (Forventet)

1. desember 2018

Studiet fullført (Forventet)

1. desember 2018

Datoer for studieregistrering

Først innsendt

2. oktober 2018

Først innsendt som oppfylte QC-kriteriene

7. oktober 2018

Først lagt ut (Faktiske)

10. oktober 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • S-1 maintenance study

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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