Clinical trial NCT02036164: Adjuvant Chemotherapy for Locally Advanced Cervical Cancer
Official title: Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uterine Cervical Cancer
Keywords: Locally advanced cervical cancer
Concurrent chemoradiation
Adjuvant chemotherapy
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
name: Navamindradhiraj University
name: Chiang Mai University
name: Prince of Songkla University
name: Bhumibol Adulyadej Hospital
name: Lopburi Cancer Hospital
name: Ubonratchathani Cancer Hospital
name: Udonthani Cancer Hospital
name: Chonburi Cancer Hospital
name: Lampang Cancer Hospital
name: Health Intervention and Technology Assessment Program
name: Rajburi Hospital
First posted: 2014-01-14
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.

Detailed description: Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.

This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Cervical cancer FIGO stage IIB-IVA
* Histopathology of 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 (WBC \> or = 3,000/mm3, granulocytes \> or = 1,500/mm3, platelet count \> or = 100,000/mm3)
* Bilirubin \< 1.5 folds, SGOT/ SGPT \< 1.5 folds of normal limit, creatinine clearance \> or = 40 mg/dl
* Consent to participate

Exclusion Criteria:

* Para-aortic lymph node enlargement \> 1 cm or suspicious for cancer metastasis from CT or MRI
* Adnexal mass from physical examination or imaging study
* Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
* Pregnancy or lactation

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
measure: Response rate
timeFrame: 4 months after completion of CCRT
measure: Cost-utility analysis
timeFrame: Cost of treatment and quality of life will be assessed at baseline, completion of CCRT, q month for 3 months after CCRT, after each cycle of ACT, 2 years after completion of treatment, and when there are tumor persistence, progression or recurrence
measure: Adverse event
timeFrame: up to 6 months after treatment
Locations:
city: Muang
country: Thailand
facility: Ratchaburi Hospital
state: Ratchaburi
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University
city: Bangkok
country: Thailand
facility: Health Intervention and Technology Assessment Program
city: Chiang Mai
country: Thailand
facility: Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University
city: Chonburi
country: Thailand
facility: Chonburi Cancer Hospital
city: Lampang
country: Thailand
facility: Lampang Cancer Hospital
city: Lopburi
country: Thailand
facility: Lopburi Cancer Hospital
city: Songkla
country: Thailand
facility: Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University
city: Ubonratchathani
country: Thailand
facility: Ubonratchathani Cancer Hospital
city: Udonthani
country: Thailand
facility: Udonthani Cancer Hopital
Study officials:
affiliation: Navamindradhiraj University
name: Siriwan Tangjitgamol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang Mai University
name: Vichan Lordvithaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. doi: 10.3802/jgo.2019.30.e82. Epub 2019 Apr 10.