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- Klinische proef NCT02204306
Genotype Guided Chemotherapy in Gastric Cancer Patients
TSER Genotype Guided Chemotherapy in Metastatic Gastric Cancer Patients: A Phase II Study in China
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
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Hunan
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Changsha, Hunan, China, 410005
- Institute of Clinical Pharmacology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the stomach.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
- No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is permitted if the disease free interval has been longer than 12 months.
- Age between 18 and 70 years. Because no dosing or adverse event data are currently available on the use of these regimens in patients <18 years of age, children are excluded from this study.
- Life expectancy of greater than 3 months.
- ECOG performance status < 2 (Karnofsky >60%; see Appendix A).
Patients must have normal organ and marrow function as defined below:
- Leukocytes >3,000/microliter
- Absolute neutrophil count >1,500/microliter
- Platelets >100,000/microliter
- Total bilirubin < 1.5 x ULN
- AST(SGOT)/ALT(SGPT) <2.5 x ULN if not liver metastases < 5 x ULN if known liver metastases
- Creatinine clearance <1.5 x ULN
Not pregnant. Not breast feeding. If the patient or partner is of childbearing potential, the couple will use adequate birth control in accordance with local IRB policies:
For woman of childbearing potential:
Patient must have negative blood pregnancy test. If sexually active, woman must either be post-menopausal (over age 50 and have not had a menstrual period for one year or more, or blood FSH level in the post-menopausal range) OR agree to use appropriate contraceptive measures for the duration of the study and for 21 days after stopping study treatment. The only birth control methods for women that are acceptable for this study are: (1) surgical sterilization (previous removal of the uterus or both ovaries or a tubal ligation) OR (2) an intrauterine device (IUD), (3) double barrier methods, (4) oral contraceptives.
For men:
Medically acceptable contraceptives include: (1) surgical sterilization, or (2) a condom used with a spermicide. If the female partner becomes pregnant while patient is on treatment or within 21 days after stopping treatment, the study physician must be informed.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients may not be receiving any other chemotherapy agents.
- Patients with known active brain metastases. Patients with treated brain metastases are permitted if stable off steroids for at least 30 days. A screening head CT/MRI is not required in asymptomatic patients for this protocol.
- History of allergic reactions to 5-FU, oxaliplatin, docetaxel, or cisplatin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the chemotherapies.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: TSER *2/*2 *2/*3
Patients with TSER *2/*2 *2/*3 genotypes will be assigned to this group and receive standard chemotherapy contains fluorouracil.
(FOLFOX 6/XELOX/SOX)
|
TS gene will be genotyped for each patients prior to chemotherapy.
Patients will be assigned to different arms according to specific TSER genotype.
Andere namen:
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Ander: TSER*3/*3 (fluorouracil)
Patients with TSER*3/*3 genotype will be randomly assigned to fluorouracil group (FOLFOX 6/XELOX/SOX) or non-fluorouracil group (DC or DO).
|
TS gene will be genotyped for each patients prior to chemotherapy.
Patients will be assigned to different arms according to specific TSER genotype.
Andere namen:
|
Ander: TSER*3/*3 (non-fluorouracil)
Patients with TSER*3/*3 genotype will be randomly assigned to fluorouracil group (FOLFOX 6/XELOX/SOX) or non-fluorouracil group (DC or DO).
|
TS gene will be genotyped for each patients prior to chemotherapy.
Patients will be assigned to different arms according to specific TSER genotype.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
disease control rate
Tijdsspanne: 6 and 12 weeks after the first chemotherapy
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Determine whether the disease control rate (DCR) at 6 and 12 weeks in TSER*3/*3 patients with metastatic gastric cancer will be increased by using a non fluoropyrimidine containing regimen compared to fluoropyrimidine-containing regimens.
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6 and 12 weeks after the first chemotherapy
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
time to progression
Tijdsspanne: 2 years maximum
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TTP is defined in this study as: "The length of time from the date of the start of treatment for gastric cancer until the disease starts to get worse or spread to other parts of the body."
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2 years maximum
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median overall survival
Tijdsspanne: 2 years maximum
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median overall survival is defined in this study as: "The length of time from the start of treatment for a disease that half of the patients in a group of patients diagnosed with the disease are still alive."
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2 years maximum
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
drug toxicities
Tijdsspanne: 2 years maximum
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Drug toxicities will be recorded and evaluated by NCI CTCAE v3.0.
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2 years maximum
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1000 Talents-CSU-GC
- 1000 Plan (Andere identificatie: 1000 Plan Program)
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Klinische onderzoeken op Uitgezaaide maagkanker
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RSP Systems A/SVoltooid
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Medtronic - MITGVoltooid
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State University of New York - Upstate Medical...BeëindigdGastric Bypass-statusVerenigde Staten
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Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IngetrokkenGastric Bypass-operatie
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Olympus Corporation of the AmericasUnity Health TorontoVoltooid
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidRoux en Y Gastric BypassVerenigde Staten
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North Dakota State UniversityNational Institutes of Health (NIH)VoltooidRoux en Y Gastric Bypass ChirurgieVerenigde Staten
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidSleeve gastrectomie | Roux en Y Gastric BypassVerenigde Staten
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Medical University of South CarolinaVoltooidGastric Bypass Chirurgie PijnbestrijdingVerenigde Staten
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Rijnstate HospitalVoltooid
Klinische onderzoeken op TSER
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Washington University School of MedicineGateway for Cancer ResearchIngetrokken