Uterine Cervical Cancer
Conditions
Keywords
Locally advanced cervical cancer, Concurrent chemoradiation, Adjuvant chemotherapy
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.
Interventions
RADIATIONPelvic radiation
Radiation: * Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks * Brachytherapy 30-35 Gy for 4-5 times
DRUGCisplatin
Cisplatin 40 mg/m2 i.v.
DRUGPaclitaxel
Paclitaxel 175 mg m2 i.v.
DRUGCarboplatin
Carboplatin AUC 5 i.v.
Sponsors
National Research Council of Thailand
Navamindradhiraj University
Chiang Mai University
Prince of Songkla University
Bhumibol Adulyadej Hospital
Lopburi Cancer Hospital
Ubonratchathani Cancer Hospital
Udonthani Cancer Hospital
Chonburi Cancer Hospital
Lampang Cancer Hospital
Health Intervention and Technology Assessment Program
Rajburi Hospital
Siriwan Tangjitgamol, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | 3-year progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | 3-year overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 4 months after completion of CCRT | 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) |
| Cost-utility analysis | 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 | Cost and quality of life |
| Adverse event | up to 6 months after treatment | Adverse events occurred during and after treatment |
Countries
Thailand
Contacts
Primary ContactSiriwan Tangjitgamol, MD
Backup ContactVichan Lordvithaya, MD
Outcome results
None listed