Adjuvant chemotherapy for locally advanced cervical cancer patients

Phase 3

Active, not recruiting

• Conditions: ocally advanced cervical cancer (FIGO stage IIB- IVA); Locally advanced cervical cancer; Concurrent chemoradiation; Adjuvant chemotherapy

• Registration Number: TCTR20140106001
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-06
• Study Completion: 2015-07-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

Patients must have:
-aged 18-70 years
-Cervical cancer FIGO stage IIB-IVA
-squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
-ECOG performance status 0-2
-No history of other cancer except basal cell carcinoma
-adequate bone marrow function) â´ÂÁÕ white blood cell > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3
-bilirubin < 1.5 folds and SGOT/ SGPT < 1.5 folds of normal limit and creatinine clearance > or = 40 mg/dl

Exclusion Criteria

-had para-aortic lymph node enlargement more than 1 cm or suspicious for cancer metastasis from CT or MRI
-had adnexal mass from physical examination or imaging study
-had chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
-Pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival 3 years Kaplan Mier

Secondary Outcome Measures

Name	Time	Method
Overall survival 3 years Kaplan Mier,response rate end of tretament percentages of response,Cost-utility analysis during and after treatment Cost & EQ-5D,side effects during and after treatment percentages