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PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy

PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy - PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016416
Enrollment
35
Registered
2015-02-02
Start date
2015-02-02
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

mFOLFOX6

Sponsors

Aichi Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma of gastric or esophagogastric junction. 2) Presence of inoperable recurrent or metastatic disease. 3) Received fluoropirimidines, cisplatin and either taxanes and irinotecan before as anticancer treatment for advanced gastric cancer. 4) Male or female patients >=20 years old at the time of informed consent. 5) ECOG performance status of 0 or 1. 6) Presence of at least one measurable disease as defined by RECIST version 1.1. 7) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with symptomatic brain metastases. 2) Requires perodial drainage of pleural fluid, ascites or pericardial effusion. 3) Received chemotherapy, radiotherapy, surgical or any other experimental therapies as anticancer treatment within 14 days before the first administration of this trial. 4) Previous treatment with oxaliplatin. 5) Concurrent uncontrolled medical condition including active infection, hypertension, diabetes mellitus, pulmonary, cardiac or psychiatric disease 5) known or suspected of not being able to comply with this trial protocol.

Design outcomes

Primary

MeasureTime frame
Response rate assessed by independent review committee

Secondary

MeasureTime frame
Disease control rate, progression free survival, overall survival, adverse events, quality of life

Countries

Japan

Contacts

Public ContactSeiichiro Mitani

Aichi Cancer Center Hospital Department of Clinical Oncology

smitani@aichi-cc.jp052-762-6111

Outcome results

None listed

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