Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Phase 3

• Conditions: Uterine Cervical Cancer
• Interventions: Radiation: Pelvic radiation; Drug: Cisplatin; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT02036164
• Lead Sponsor: Siriwan Tangjitgamol, MD

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-12
• Study First Posted: 2014-01-14
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurretn chemoradiation plus adjuvant chemotherapy	Pelvic radiation	Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin * Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy * Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT * Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
Concurrent chemoradiation	Pelvic radiation	Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin - Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
Concurrent chemoradiation	Cisplatin	Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin - Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
Concurretn chemoradiation plus adjuvant chemotherapy	Paclitaxel	Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin * Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy * Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT * Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
Concurretn chemoradiation plus adjuvant chemotherapy	Cisplatin	Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin * Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy * Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT * Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
Concurretn chemoradiation plus adjuvant chemotherapy	Carboplatin	Radiation: Radiation Therapy * External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine * Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin * Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy * Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT * Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel

Primary Outcome Measures

Name	Time	Method
Progression-free survival	3 years	3-year progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	3-year overall survival

Trial Locations

Locations (11)

Udonthani Cancer Hopital; 🇹🇭 Udonthani, Thailand

Ubonratchathani Cancer Hospital; 🇹🇭 Ubonratchathani, Thailand

Health Intervention and Technology Assessment Program; 🇹🇭 Bangkok, Thailand

Lampang Cancer Hospital; 🇹🇭 Lampang, Thailand

Chonburi Cancer Hospital; 🇹🇭 Chonburi, Thailand

Lopburi Cancer Hospital; 🇹🇭 Lopburi, Thailand

Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University; 🇹🇭 Songkla, Thailand

Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University; 🇹🇭 Bangkok, Thailand

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Ratchaburi Hospital; 🇹🇭 Muang, Ratchaburi, Thailand

Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand