LUFT Trial

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2019
INTERVENTION: 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. CONDITION: cervical cancer (squamous cell carcinoma, adenosquamous carcinoma, and adenocarcinoma) ; Cervical Carcinoma of the Uterus PRIMARY OUTCOME: Progression‐free survival SECONDARY OUTCOME: Overall Survival/Adverse event/Quolity of Life/Lost effectiveness INCLUSION 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 follo
Epistemonikos ID: a92dab0846396eb4e43155ee6ef812b2f832592b
First added on: Aug 24, 2024