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QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-

QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study- - QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008395
Enrollment
20
Registered
2012-07-10
Start date
2012-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

Capecitabin+CDDP (XP) Day1 to 14:Capecitabin take orally(twicw a day) Day1 CDDP:Drip infusion Day15 to 21:7 days rest S-1+CDDP (SP) Day1 to 21:S-1 take orally(twicw a day) Day8:CDDP 60mg/m2 Drip

Sponsors

Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)proven gastric adenocarcinoma R0 unresectable or reccurent gastric cancer 2)HER2 negative or unknown gastric cancer 3)patients between 20 and 75 years old 4)PS(ECOG) between 0 and 2 5)patients who not undergo chemotherapy and/or radiation therapy 6)with a good condition of important organs recent 14 days 1.WBC>=3,000/mm3 2.neutrophil>=1,500/mm3 3.platelet>=100,000/mm3 4.hemoglobin>=8.0g/dl 5.total bilirubin<=1.5mg/dl 6.AST(GOT)<=100IU/L (with hepatic metastasis <=150) 7.ALT(GPT)<=100IU/L (with hepatic metastasis <=150) 8.serum creatinine<=1.2mg/dl 9.creatinin clearance>=60ml/min 7)expected survival longer than 3 months 8)patients who can take orally 9)written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1)with prior chemotherapy and/or radiation therapy 2)patients administrated fluoropyrimidine before less than 6 months of the registration 3)with a history of platinum administrarion 4)simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.Carcinoma in situ or Cancers localized in membranous layer are not included to double cancer. 5)with symptoms of brain metastasis 6)with history of severe allergy against medicines 7)with following diseases 1.uncontrolled DM 2.uncontrolled high-blood pressure 3.liver cirrhosis and/or liver failure 4.renal failure 5.interstitial pneumonitis, pulmonary fibrosis, severe athelectasis 6.active infection diseases 7.heart failure, cardic infarction and/or severe disorder on ECG during recent 6 months 8)HBs positive status 9)with severe diarrhea (watery stool over 4 times a day) 10)patients who have flucytosine, fenitoin or walfarin 11)patients who have steroids continuously 12)women pregnant or women who like to be pregnant or males who like to have their own baby 13)patients decided not to register to this study due to psychologic diseases and/or psychological symptoms 14)patients whom doctor decide not ro register to this study

Design outcomes

Primary

MeasureTime frame
QOL evaluation

Countries

Japan

Contacts

Public ContactKoji Nakai

Kansai Medical University Department of surgery

nakaik@takii.kmu.ac.jp06-6992-1001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026