A COMPARATIVE STUDY TO EVALUATE THE DIFFERENCES IN DOSIMETRY AND TREATMENT OUTCOMES IN PATIENTS WITH LOCALLY ADVANCED CARCINOMA CERVIX UNDERGOING INTRACAVITORY BRACHYTHERAPY UNDER TWO DIFFERENT ANAESTHESIA TECHNIQUES.

AIM:

To evaluate efficacy and dosimetric superiority of epidural analgesia (EA) over procedural sedation (PS) in patients with locally advanced carcinoma cervix undergoing high dose rate intracavitory brachytherapy(HDR-ICBT).

OBJECTIVES:

To compare the following parameters between 2 study arms-epidural analgesia (ICBT-EA) vs procedural sedation (ICBT-PS).

Primary objective:

To compare the radiation dose received by 2cc (D2cc) bladder, rectum, sigmoid colon between 2 study arms.

Secondary objective:

To compare

1. Pain intensity score by using numeric rating scalr (NRS)

2. Tumor response rate.

3. Late radiation toxicities – proctitis, cystitis.

INCLUSION CRITERIA:

1. Age : 18 years or older

2. International Federation of Gynaecology and Obstetrics (FIGO) stage IB3, II, III, IVA

3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (PSS): 0-2

4. Patients who are willing to give informed consent to participate in the study.

EXCLUSION CRITERIA:

1. Carcinoma cervix patients who underwent surgery

2. Carcinoma cervix patients who underwent prior radiotherapy.

3. ECOG PSS : 3-4

4. Stage IVA disease with vesicovaginal fistula (VVF), rectovaginal fistula (RVF), stage IVB

5. Pregnant women and lactating mothers

SAMPLE SIZE

Sample size is calculated based on mean dose received by rectum in previous study.

Assuming, Alpha error of 0.05 (95% Confidence limit), Power of 80%, Ratio of EA vs PS group 1:1

The number of subjects required in Arm A and Arm B was calculated to be 25 in each group.

Hence total sample size is 50 subjects.

The study sample size - the patients who satisfy inclusion criteria and recruited during the study period.

ASSESSMENT OF OBJECTIVES

Dosimetric Data:

Radiotherapy treatment plans will be generated on TPS computers for each patient in both arms.

The dosimetric data i.e, the dose received by the OARs, D2cc of bladder, rectum, and sigmoid colon will be collected and recorded.

Pain intensity:

Pain intensity will be assessed using either Visual analog scale (VAS) or Numeric rating scale (NRS) .

Clinical outcome measures:

1. All study participants will be called for follow-up, first once a month for 3 months, then 3 monthly for the next 9 months, then 6 monthly thereafter.

2. The tumor response for 3 months will be evaluated as per the Response Evaluation Criteria in Solid Tumors (RECIST) .

3. Acute and late toxicities will be evaluated as per the RTOG criteria.

DATA COLLECTION:

All data related to study participants will be collected in the predesigned proforma.

All the collected data from each study participant will be entered into Microsoft Excel.

STATISTICAL ANALYSIS:

Data will be collected on a predesigned proforma and will be entered in Microsoft Excel Worksheet (Windows 11; Version 2021) and analysed using the Statistical Package for Social Science (SPSS) standard version 20 (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). All continuous variables such as dosimetric parameters will be summarised using Mean (SD) or Median (IQR) depending on the normality of the distribution. Categorical variables such as toxicities will be summarised using proportions. Comparison of continuous variables across study groups (EA group vs PS group) will be done using unpaired t-test. Comparison of categorical variables across study groups will be done using Chi square test. P-value of <0.05 will be considered statistically significant.