Randomised trial to study the additional impact of brachytherapy (internal radiation) over high precision external radiotherapy for reduction of dryness of mouth in patients with early stage cancer of oropharynx.

A randomised trial comparing modulated external beam radiation alone vs intensity modulated radiation and brachytherapy for reduction in xerostomia in patients with early staged oropharyngeal cancers.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001329

Enrollment

157

Registered

2010-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- head and neck cancers

Interventions

Intervention1: Intensity Modulated Radiation therapy: NA Control Intervention1: Intensity Modulated Radiation therapy +Brachytherapy: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with OPC 2.Willing for definitive treatment at TMH 3.Early stage T1-2N0M0 4.Squamous cell carcinoma 5.Age>18 6.Fit for radical treatment 7.Karnofsky Performance score >60 8.No prior history of therapeutic irradiation 9.Normal liver and renal functiontests. 10.Informed Consent 11.Tumor topology suitable for BT 12.Willing for follow up and follow up investigations

Exclusion criteria

Exclusion criteria: 1.Patients unfit for BT procedure due to medical comorbidities 2.Advanced stage T3,4/N1-3/M1 disease 3.Prior history of malignancy 4.Pregnancy and lactating women 5.Non squamous histology 6.Tumor topology not suitable for BT.

Design outcomes

Primary

Measure	Time frame
Reduction in the xerostomia evaluated at 6 months.Timepoint: NA;To compare the local control rates, disease free and overall survival in two two groups.Timepoint: NA;To study quality of life in the two groups. To assess reduction in doses to constrictirs and larynx with the two modalities.Timepoint: NA	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Ashwini Budrukkar

ashwininb@yahoo.com91 22 24177152

Outcome results

None listed

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