Cervical cancer, FIGO stage IB-IVA. Malignant neoplasm of cervix uteri
Conditions
Interventions
Intervention 1: Intervention group: patients who are eligible to enter the trial, are put on Capecitabine 825mg/m2 twice daily during their brachytherapy treatment, starting from the first fraction of
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: definite diagnosis of cervical cancer in the pathological sample histology of SCC or Adenocarcinoma stage IB-IVA based on gynecologic examination and imaging, making these patients chemoradiotherapy candidates no evidence of distant metastasis adequate performance status ( ECOG =2)
Exclusion criteria
Exclusion criteria: not willing to enter the trial uncontrolled comorbidities, like diabetes mellitus and hypertension warfarin use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival. Timepoint: every 3 months after intervention for 12 months. Method of measurement: Using patients' registries, which are the result of patient's follow up visits every three months after completion of treatment to the treating doctor. Recurrence could be proved using biopsy or imaging.;Acute Gastrointestinal side effects: nausea and vomiting. Timepoint: During each brachytherapy session. which happens every second or third day. Method of measurement: By history taking, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.;Acute gastrointestinal side effects: diarrhoea. Timepoint: During each brachytherapy session, which happens every second or third day. Method of measurement: By history taking, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.;Acute hematologic side effects: Anemia. Timepoint: during every brachytherapy session which is done every second or third day or weeky during intervention. Method of measurement: By history taking, and looking for signs of cytopenias, like bruises, fever, weakness and mucositis. In case of suggesting history, Complete blood count is requested, otherwise a routine Complete blood count is done weekly.;Acute hematologic side effects: leucopenia. Timepoint: During every brachytherapy session which is done every second or third day or weeky during intervention. Method of measurement: By history taking, and looking for signs of leukopenia, like fever and mucositis. In case of suggesting history, Complete blood count is requested, otherwise a routine Complete blood count is done weekly.;Hand foot syndrome. Timepoint: During each brachytherapy session, which happens every second or third day. Method of measurement: By physical examination, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute hematologic side effect: Thrombocytopenia. Timepoint: Every brachytherapy session, which happens every second or third day. Method of measurement: By history taking, asking for any bleeding or bruises, in case of positive history a complete blood count is requested. In case of negative history, a complete blood count is routinely done weekly during brachytherapy treatment, which takes ten to fourteen days,.;Overall survival( survival from the time of diagnosis till death). Timepoint: every 3 months after the intervention. Method of measurement: Results of 12 months of follow up of patients regarding overall survival will be recorded using patient's records or in case of lack of adherence to follow up, through phone call. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoudeh Arastouei
Mashhad University of Medical Sciences
Outcome results
None listed