Tongue-preserving treatment using brachytherapy and intensity-modulated radiation therapy technique for localized tongue cancer

Plain English summary of protocol

Background and study aims
Surgery is usually the standard treatment for early and some locally advanced tongue squamous cell carcinoma (TSCC). However, using an organ-preserving approach that includes interstitial brachytherapy (IBT) can control the cancer just as effectively. Using external beam radiotherapy (EBRT) alone for oral tongue cancer has generally produced poor results. Outcomes improve when EBRT is combined with interstitial brachytherapy and, in some cases, neck surgery, achieving results similar to surgery alone. This is likely because it is difficult for EBRT alone to reliably deliver a high enough radiation dose to the tongue, as the tongue moves and its position changes daily. Surgical cancer control depends on removing enough tissue to achieve clear margins, but speech and swallowing outcomes depend on how much tongue remains. For larger tumours, or those involving the floor of the mouth, IBT offers a way to preserve the tongue while still maintaining good cancer control and function. Most previous studies used EBRT followed by brachytherapy, and many patients then required additional neck surgery for persistent disease. More recent studies show that EBRT can provide reasonable long-term control of disease in the neck, even without planned neck surgery. IBT provides excellent local control of the tongue tumour, with very high control rates reported in early to moderately advanced disease. Combining IBT for the tongue with EBRT for the neck offers a balanced approach: strong local tumour control while also treating regional lymph nodes, often without the need for neck surgery. Because of practical challenges with delivering brachytherapy after EBRT, our centre adopted a reversed approach: delivering brachytherapy first, followed by modern IMRT, with or without chemotherapy, from January 2019 onwards. The initial results from the first eleven patients treated with this approach were presented at an international radiation oncology meeting in 2023. Most of these early patients were alive, free of cancer, and had good speech and swallowing function at one year, suggesting this approach is promising. To our knowledge, this is the first study to formally describe this treatment sequence, known as hybrid brachytherapy followed by adaptive IMRT (HyBIRT). This study of patients treated with the HyBIRT technique will collect detailed information on treatment delivery, side effects, tumour control, survival, and quality of life at regular time points. The results will be compared with previously published surgical outcomes to assess whether HyBIRT can be a suitable alternative for selected patients. The aim of this study is to assess cancer control, side effects, treatment accuracy, and quality of life in patients treated with HyBIRT and to compare these results with historical surgical data.

Who can participate?
Patients aged 18 years and over with biopsy-proven TSCC affecting the front two-thirds of the tongue

What does the study involve?
Participants will receive HyBIRT treatment, which has two main stages. First, internal radiotherapy (brachytherapy) delivers a focused radiation dose directly to the tongue tumour over five treatment sessions. This is followed by highly precise external radiotherapy (IMRT) to the tongue and neck, tailored to the individual patient. During this phase, most patients also receive weekly chemotherapy, following standard hospital practice.

What are the possible benefits and risks of participating?
This treatment may control the cancer as effectively as surgery, while helping to preserve tongue function and quality of life. The approach aims to treat the cancer effectively while avoiding the long-term speech and swallowing problems that may follow tongue surgery. Risks include short-term and long-term side effects from radiotherapy and chemotherapy. A rare but serious long-term risk is damage to the jawbone caused by radiation. More common side effects include mouth soreness, swallowing difficulties, dry mouth, and tissue stiffness, most of which improve over time. Patients will be closely monitored so that any side effects can be identified and treated early.

Where is the study run from?
Pusat Kanser Tun Abdullah Ahmad Badawi (PKTAAB), Universiti Sains Malaysia

When is the study starting and how long is it expected to run for?
October 2021 to December 2030

Who is funding the study?
Universiti Sains Malaysia

Who is the main contact?
Associate Professor Dr Gokula Kumar Appalanaido, gokula@usm.my , gokudroid@gmail.com

Contact information

Prof Gokula Kumar Appalanaido
Principal investigator, Scientific, Public

Pusat Kanser Tun Abdullah Ahmad Badawi, Universiti Sains Malaysia, 13200 Bertam
Kepala Batas
13200
Malaysia

ORCID ID	0000-0002-6763-0942
Phone	+60 (0)45622701
Email	gokula@usm.my

Study information

Eligibility

Locations

Countries of recruitment

• Malaysia

Study participating centre

Results and Publications

Editorial Notes

10/04/2026: Study's existence confirmed by the Jawatankuasa Etika Penyelidikan (Manusia), JEPeM Universiti Sains Malaysia Human Research Ethics Committee USM (HREC).