Invasive cervical lesion Cervical Cancer
Conditions
Interventions
This is a phase III open-label randomized controlled clinical trial with two parallel arms where a total of 350 eligible women with locally advanced cervical cancer will be randomly allocated to one o
Sponsors
Liga Norte Riograndense Contra o Câncer
Liga Norte Riograndense Contra o Câncer
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older; diagnosis of primary cervical carcinoma stages IB to IIIC, with a maximum of three positive pelvic lymph nodes and no tumor extension to the middle or lower third of the vagina or involvement of the common iliac chain; histological type adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma; no prior pelvic radiotherapy or chemotherapy; Eastern Cooperative Oncology Group performance status between zero and two; laboratory tests with adequate hematological, renal, and hepatic functions; negative pregnancy test for patients with childbearing potential
Exclusion criteria
Exclusion criteria: Histology other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; prior treatment for cervical carcinoma, except conization; other prior or current malignant neoplasms, with the exception of basal cell carcinoma of the skin, untreated and controlled chronic lymphocytic leukemia, and carcinoma in situ of the cervix, unless disease-free for at least five years; presence of ectopic pelvic kidney; laparotomy for staging or treatment; pregnant, lactating, or childbearing age women without adequate contraceptive measures; patients with distant metastases or para aortic lymph node involvement proven by imaging or biopsy; patients with other clinical conditions that preclude the use of chemotherapy or radiotherapy; patients on neoadjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate disease-free survival at three years, verified by measuring the time elapsed between the initial curative treatment and the appearance of local, regional, or distant recurrence, or death related to cancer, through the observation and recording of survival rates estimated by the kaplan meier method and compared using the log rank test;Expected outcome 1: It is expected to evaluate overall survival, verified by measuring the time elapsed between the date of initial treatment and death from any cause, using the Kaplan-Meier method and Cox regression to analyze hazard ratios and survival percentages throughout the five-year follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected to evaluate the clinical response rate to treatment, verified through the Response Evaluation Criteria in Solid Tumors version one point one, using physical and imaging examinations to analyze the percentages of complete response or partial response maintained for at least three months;Expected outcome 3: It is expected to evaluate acute and late gastrointestinal and geniturinary toxicities greater than or equal to grade two, verified through the Common Terminology Criteria for Adverse Events version six point zero, using weekly reviews and follow-up consultations to record the incidence and severity of adverse effects;Expected outcome 4: It is expected to evaluate the pattern of disease failure and recurrence, verified through physical examination, radiological studies, or pathological specimen, using post-treatment follow-up to map and document the exact location of local, regional, or distant progression;Expected outcome 5: It is expected to evaluate quality of life related to treatment, verified through the application of the validated questionnaires from the European Organization for Research and Treatment of Cancer modules C30 and CX24, using interviews before treatment, post-treatment, and at six, twelve, and twenty-four months to analyze scores and indexes of general and specific symptoms | — |
Countries
BR
Contacts
Public ContactEdilmar Santos
Liga Norte Riograndense Contra o Câncer
Outcome results
None listed