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Tumor response and toxicities in cervical cancer patients with a different brachytherapy schedule (where a radioisotope will be kept inside the vaginal cavity to provide internal radiation near the tumor) involving 5 sessions of 6 radiation units each in two applications of a catheter.

Clinical outcomes of cervical cancer with a short intra-cavitary brachytherapy schedule involving 5 sessions of 6Gy each. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068635
Enrollment
48
Registered
2024-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: Intra cavitary brachytherapy applications of cervical cancer using a different fractionation schedule: 6Grays in 5 sessions using 2 applications. In the first application, 3 sessions of

Sponsors

Dr Muhammed Basil Y P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy-proven newly diagnosed carcinoma cervix Patients fit for chemotherapy Age less than 65 years without comorbid conditions FIGO Stage IB, IIA, IIB, IIIB without lower one-third involvement ECOG 0-2 No major life-threatening complications

Exclusion criteria

Exclusion criteria: More than 65 years ECOG 3 or more Prior pelvic radiotherapy Uncontrolled Diabetes and hypertension Patients with a prior history of DVT/Pulmonary embolism Lower one-third involvement of any stage

Design outcomes

Primary

MeasureTime frame
Tumor Response in terms of partial or complete response. It will be assessed by clinical or radiological imaging.Timepoint: it will be assessed over 2 monthly follow up to 1 year. The baseline will be the initial tumor size before the application.

Secondary

MeasureTime frame
Acute toxicities like diarrhea, dermatitis, anemia, neutropenia, etc.Timepoint: Assessed weekly during radiation therapy;Late toxicities which include cystitis & proctitis etcTimepoint: 6 months up to 1 year

Countries

India

Contacts

Public ContactDr Parthasarathy V

Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER

dr_patchu2003@yahoo.co.in9443601748

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026