Locally advanced cervical cancer Locally advanced cervical cancer, Concurrent chemoradiation, Beta Glucan
Conditions
Interventions
Cisplatin 40 mg/ m2 weekly for 6 cycles in concurrent with pelvic radiation therapy plus placebo (for 3 months during CCRT) ,Cisplatin 40 mg/ m2 weekly for 6 cycles in concurrent with pelvic radiatio
Active Comparator Other,Experimental Other
Control ,Study
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients must have: - Cervical cancer FIGO stage IB2-IVA (FIGO 2018) - Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma - ECOG performance status 0-2 - No history of other cancer - 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 - Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures
Exclusion criteria
Exclusion criteria: - has received prior systemic chemotherapy or radiotherapy at any time for cervical cancer - Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI - Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection. - Pregnancy or lactation - Patients with infection or inflammatory conditions or on oral/topical antimicrobials or use antiseptic solution for vaginal wash in the past 3 weeks. - had previous exposure to beta glucan products. - Allergy to the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival 3 years Kaplan Mier | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival 3 years Kaplan Mier,Response rate 3 months after completion of CCRT percentages of response,Adverse event during or up to 6 months after treatment percentages | — |
Countries
Thailand
Contacts
Public ContactJitti Hanprasertpong
Prince of Songkla University
Outcome results
None listed