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A Randomized Phase III Trial of Adjuvant Chemotherapy with UFT following Curative Radiation Therapy for Locally Advanced Cervical Cancer

A Randomized Phase III Trial of Adjuvant Chemotherapy with UFT following Curative Radiation Therapy for Locally Advanced Cervical Cancer - A Randomized Trial of Adjuvant Chemotherapy with UFT following Curative Therapy for Locally Advanced Cervical Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003651
Enrollment
350
Registered
2010-05-24
Start date
2010-05-21
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

Stage Ib2-IVa cervical cancer with Curative Radiation Therapy

Interventions

Observation UFT 300 or 400mg/Day

Sponsors

Gynecologic Oncology Trial and Investigation Consortium
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Pathologicaly confirmed cervical cancer(squamous cell carcinoma,adenosquamous carcinoma,adenocarcinoma) 2)FIGO: Ib2, IIa, IIb, IIIa, IIIb, IVa 3)Patients who have received CCRT within 3-12 weeks and determined to be PR or CR by CT or MRI. 4)Age: 20 years old-75 years old 5)Performance status: ECOG 0-2 6)Adequate organ functions. 7)Patients who have signed to an approved informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who have received hysterectomy after radiation therapy. 2)Patients with uterine stump cancer. 3)Patients who have received NAC. 4)Patients with active infection. 5)Patients who have myocardial infarction or unstable angina or uncontrolled arrhythmia within 6 months. 6)Patients with severe complications (uncontrolled hypertension,uncontrolled diabetes,bleeding tendency,or rheumatology). 7)Patients who have had any other cancer within the past 5 years. 8)Patients with watery diarrhea. 9)Patients with psychiatric disease. 10)Patients who are pregnant or breast feeding. 11)Patients who have a history of hypersensitivity to UFT 12)Patients who are considered to be inappropriate for this study judged by the treating physician

Design outcomes

Primary

MeasureTime frame
Progression-free survival

Secondary

MeasureTime frame
Overall Suvival/Adverse event/Quality of Life/Cost effectiveness

Countries

Japan

Contacts

Public ContactKeiichi Fujiwara

GOTIC002 Coordinating Office Saitama Medical University International Medical Center

fujawara@saitama-med.ac.jp042-984-4111

Outcome results

None listed

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