Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Uterine Cervical Cancer Clinical Trial

— ACT-LACC  

Official title:

Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02036164
• Other study ID #: COA-CREC 002/2013
• Secondary ID: 20140106001
• Status: Recruiting
• Phase: Phase 3
• First received: January 8, 2014
• Last updated: April 4, 2017
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: April 2017
• Source: Navamindradhiraj University
• Contact: Siriwan Tangjitgamol, MD
• Phone: 66-86-3841431
• Email: siriwanonco[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Pelvic radiation
Radiation: Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks Brachytherapy 30-35 Gy for 4-5 times

Drug:
• Cisplatin
Cisplatin 40 mg/m2 i.v.
• Paclitaxel
Paclitaxel 175 mg m2 i.v.
• Carboplatin
Carboplatin AUC 5 i.v.

Locations

Country	Name	City	State
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University	Bangkok
Thailand	Health Intervention and Technology Assessment Program	Bangkok
Thailand	Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University	Chiang Mai
Thailand	Chonburi Cancer Hospital	Chonburi
Thailand	Lampang Cancer Hospital	Lampang
Thailand	Lopburi Cancer Hospital	Lopburi
Thailand	Ratchaburi Hospital	Muang	Ratchaburi
Thailand	Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University	Songkla
Thailand	Ubonratchathani Cancer Hospital	Ubonratchathani
Thailand	Udonthani Cancer Hopital	Udonthani

Sponsors (13)

Lead Sponsor	Collaborator
Siriwan Tangjitgamol, MD	Bhumibol Adulyadej Hospital, Chiang Mai University, Chonburi Cancer Hospital, Health Intervention and Technology Assessment Program, Lampang Cancer Hospital, Lopburi Cancer Hospital, National Research Council of Thailand, Navamindradhiraj University, Prince of Songkla University, Rajburi Hospital, Ubonratchathani Cancer Hospital, Udonthani Cancer Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response rate	Response rate will be assessed at 4 months after completion of CCRT (expected to be at 4 months after CCRT in the control arm or at 1 month after completion of adjuvant chemotherapy in the study arm)	4 months after completion of CCRT
Other	Cost-utility analysis	Cost and quality of life	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
Other	Adverse event	Adverse events occurred during and after treatment	up to 6 months after treatment
Primary	Progression-free survival	3-year progression free survival	3 years
Secondary	Overall survival	3-year overall survival	3 years