- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01472250
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.
Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 100142
- Lin Shen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
- The informed consent form is signed.
- A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
- ECOG performance status is 0, 1 or 2.
- The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
- The patient is aged≥18
Exclusion Criteria:
- The patient is known to be allergic to any study drug.
- The patient is recruited in other clinical study or is planned to participate into other clinical study.
- The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
chemotherapy
Eligible patients will accept generalized chemotherapy according to the investigator's assessment.
|
Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below: Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
chemotherapy regimen
Tidsram: 2 months
|
To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China
|
2 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
overall survival
Tidsram: 2 months
|
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost
|
2 months
|
quality of life
Tidsram: 6 weeks
|
To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice
|
6 weeks
|
treatment expense
Tidsram: 2 months
|
To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice
|
2 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CGOG1002
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