LUFT Trial

JRCT ID: jRCTs031180174

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cervical cancer (squamous cell carcinoma, adenosquamous carcinoma, and adenocarcinoma)
• Date of first enrollment: 11/06/2010
• Target sample size: 350
• Study type: Interventional

Intervention(s)

Group A: Follow-up group (control group)
Subjects allocated to the follow-up group are administered no drugs following curative treatment and followed up on without any treatment with anticancer drugs until disease progression/relapse.
Group B: UFT adjuvant chemotherapy group (study treatment group)
The administration of UFT is initiated within 2 weeks following enrollment. UFT is continuously administered at 400 mg/day or 300 mg/day according to the body surface area, twice daily, in the morning and evening, for 24 months.
Following the completion of 24-month administration of UFT, no treatment with anticancer drugs is given until disease progression/relapse. In case of discontinuation of UFT administration due to adverse events, the date on which the last dose of UFT is administered shall be the end date for the study treatment.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall Survival/Adverse event/Quolity of Life/Lost effectiveness

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include criteria

1)Patients with histologically proven primary cervical cancer (squamous cell carcinoma, adenosquamous carcinoma, and adenocarcinoma)
2)Patients with FIGO stages Ib2, IIa, IIb, IIIa, IIIb, and IVa cervical cancer
3)Patients who have completed curative treatment 3 or more weeks and within 12 weeks earlier and have a partial response (PR) or better confirmed by imaging (CT or MRI) (the same imaging conditions must be used before and after treatment)
*Curative treatment
Concurrent chemoradiation therapy must include radiation therapy consisting of external irradiation (whole pelvis irradiation) and intracavitary irradiation, and platinum-based chemotherapy
The post-curative treatment period shall be counted from the last day the subject received the curative treatment (Day 0).
4)Patients aged 20-75 years at enrollment
5)Patients with an ECOG Performance Status of 0 to 2
6)Patients with adequate function of vital organs who fully satisfy the following criteria (ECG must be completed within 28 days of enrollment and laboratory tests excluding ECG must be completed 14 days before enrollment):
Neutrophil count:>=1,500/mm3(Or white blood cell count of >=2,500/mm3 when there is difficulty in measuring neutrophil count)
Hemoglobin:>=8.0 g/dL(Hemoglobin adjustment by transfusion is acceptable)
Platelet count:>=100,000/mm3
AST (GOT), ALT (GPT): <100
Al-p:<750 IU/L
Serum total bilirubin:<1.5 mg/dL
Serum creatinine:<1.5 mg/dL
ECG: Within the normal range or asymptomatic but having an abnormality not requiring treatment
7)Patients who have voluntarily given written informed consent to participate in this study

Exclude criteria

1)Patients who have undergone hysterectomy following radiation therapy
2)Patients with cervical stump cancer
3)Patients who received curative radiation therapy following neoadjuvant chemotherapy (NAC)
4)Patients with active infections (who have a fever of >=38.5c and bacterial infection proved by diagnostic imaging or bacteriological examinations)
5)Patients who have had myocardial infarction, unstable angina, or uncontrolled arrhythmia within 6 months before enrollment
6)Patients with serious complications (uncontrolled hypertension or diabetes mellitus, bleeding tendency, or connective tissue disorders requiring steroid treatment)
7)Patients with active multiple cancers (synchronous multiple cancers or metachronous multiple cancers with disease-free interval at <=5 years , excluding carcinoma in situ or any cancerous lesions equivalent to intramucosal carcinoma determined to be cured by local treatment)
8)Patients with diarrhea (watery stool)
9)Patients with concurrent psychiatric symptoms who are deemed unsuitable for study participation
10)Patients who are pregnant, who may be pregnant, or who are breastfeeding
11)Patients with a history of serious hypersensitivity to the ingredients of UFT
12)Patients who have been judged ineligible to participate in the study by the principal investigator or sub investigator.

Related Information

• Primary Sponsor: FUJIWARA Keiichi
• Secondary Sponsor: Gynecologic Oncology Trial and Investigation Consortium
• Secondary ID(s): UMIN000003651