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A study comparing two types of Anaesthesia in cervical cancer Brachytherapy.

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. - DLACTA - ICBT Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107745
Enrollment
50
Registered
2026-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri

Interventions

Intervention1: EPIDURAL ANAESTHESIA: ICRT under EPIDURAL ANAESTHESIA Intervention2: EPIDURAL ANAESTHESIA: Dosimetry differences and treatment outcomes in patients undergoing ICRT under Epidural anaest

Sponsors

SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: 1. Age : 18 years or older 2. International Federation of Gynaecology and Obstetrics (FIGO) stage (11) : 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

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

Design outcomes

Primary

MeasureTime frame
To compare the radiation dose received by 2cc (D2cc) bladder, rectum, sigmoid colon between 2 study arms-epidural analgesia (ICBT-EA) vs procedural sedation (ICBT-PS).Timepoint: During treatment.

Secondary

MeasureTime frame
To compare 1. Pain intensity score by using numeric rating scalr (NRS) 2. Tumor response rate. 3. Late radiation toxicities proctitis, cystitis.Timepoint: During treatment, after 1 month, 3 months,6 months, 9 months, 12 months.

Countries

India

Contacts

Public ContactDrPranabandhu Das

Sri Venkateswara Institute of Medical Sciences

daspranabandhu@gmail.com9493547731

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026