Paclitaxel plus cisplatin as adjuvant chemotherapy for advanced cervical cancer

JRCT ID: jRCTs051180220

Registered date:27/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Uterine cervical cancer
• Date of first enrollment: 14/09/2015
• Target sample size: 125
• Study type: Interventional
• Intervention(s): TP (135mg/m2 paclitaxel and 50mg/m2 cisplatin, six courses for the patients who had lymph node metastasis and three courses for the others.)

Outcome(s)

• Primary Outcome: Two-year disease free survival rate
• Secondary Outcome: Adverse events rate, completion rate of chemotherapy, 5-year survival rate, 5-year disease free survival rate, lymph edema rate

Key inclusion & exclusion criteria

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

Include criteria

(1) Uterine cervical cancer confirmed by histology
(2) Pathological findings
More than half cervical stromal invasion and positive lymphovascular space invasion

Exclude criteria

(1) Active infection
(2) Severe complication
(3) Multiple primary cancers with disease-free period less than 5 years, except carcinoma in situ or intra mucosal disease curedby local therapy
(4) Interstitial pneumonia, pulmonary fibrosis
(5) Massive ascites, massive pleural infusion
(6) Allergy to paclitaxel or cisplatin
(7) Severe allergy to medicine
(8) The patient who is not safe to include in this study

Related Information

• Primary Sponsor: Sumi Toshiyuki
• Secondary ID(s): UMIN000035856