Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
MNJ Institute Of Oncology
Eligibility
Inclusion criteria
Inclusion criteria: Female, age 18 years or older. Histologically confirmed cervical carcinoma (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). FIGO 2018 Stage IB2 to IIIB. Planned for definitive external beam radiotherapy 45 to 50.4 Gray in 25 to 28 fractions with concurrent weekly cisplatin 40 milligrams per square metre followed by intracavitary high dose rate brachytherapy. MRI of the pelvis performed as part of standard pre-treatment workup. Uterus intact and suitable anatomy for intracavitary brachytherapy. ECOG Performance Status 0 to 2. Adequate renal function with creatinine clearance of 50 millilitres per minute or more. Ability to attend weekly assessments during the external beam radiotherapy course. Written informed consent obtained in the preferred language of the patient.
Exclusion criteria
Exclusion criteria: Prior pelvic radiotherapy. Stage IVA or IVB disease at enrolment. Small cell, neuroendocrine, or sarcomatous histology. Prior hysterectomy. Contraindication to transvaginal ultrasound due to active lower genital tract infection or patient refusal. Pre-brachytherapy MRI of the pelvis or CT scan with applicator in situ at the time of brachytherapy cannot be performed. Baseline tumor not measurable on ultrasound at the time of enrolment. Pregnancy. Concurrent enrolment in any interventional trial that modifies external beam radiotherapy delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the correlation between tumor regression kinetics measured by serial ultrasound and bimanual examination at weeks 0, 2, and 4 of EBRT, and HRCTV volume (defined on pre-brachytherapy MRI) at the time of first brachytherapy fraction.Timepoint: end of phase 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Develop a multivariate regression model (nomogram) predicting HRCTV volume at brachytherapy from clinical and ultrasound regression parametersTimepoint: End of phase 1;Determine predictive accuracy of the model for classifying HRCTV as less than or equal to 30 cc versus greater than 30 ccTimepoint: at the end of phase 1;Evaluate the rate and pattern of tumor regression kinetics during EBRT in this populationTimepoint: At the end of phase 1;Assess reproducibility of serial ultrasound measurementsTimepoint: at the end of phase 1;Identify clinical predictors of poor regression, residual tumor greater than 4 cm at brachytherapyTimepoint: at the end of phase 1;Correlate predicted versus actual HRCTV with achieved brachytherapy dosimetric parameters (HRCTV D90, OAR D2cc)Timepoint: end of phase 2 | — |
Countries
India
Contacts
Public ContactDr Ravitej Athota
MNJ Institute of Oncology
Outcome results
None listed