Clinical trial · Interventional
Radiation Therapy Using Helical Tomotherapy IMRT for Head and Neck Cancer
Helical Tomotherapy Intensity Modulated Radiotherapy:A Phase I/II Pilot Study to Determine the Toxicity Profile, Pattern of Failures and Quality of Life of Patients With Squamous Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Historically, patients with stage III and IV head and neck cancer have been treated with surgery and/or radiation therapy. Based on the results of recent clinical trials, in patients not able to undergo surgery, chemotherapy with radiation therapy has been adopted as the current standard of care. The chemo-radiation approach, however, entails a significant increase in treatment-related toxicity, limiting the extent to which this treatment can be offered to patients. In this trial, the ability of a new form of radiation therapy delivery called IMRT will be evaluated for its ability to reduce the amount of radiation-induced toxicity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiotherapy
- description
- Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) with the intend of delivering radical radiotherapy to a dose of 66-70 Gy to involved areas and at least 50 Gy to un-involved sites to be treated prophylactically.
- interventionNames
- Procedure: Radiotherapy
Primary outcomes (1)
- measure
- 1) To determine the toxicity profile of patients with head and neck cancer treated with helical tomotherapy-IMRT
- timeFrame
- weekly
- description
- MEASURING MUCOSITIS
Secondary outcomes (1)
- measure
- 1) To compare the dose distributions generated by HT-IMRT with those generated using three-dimensional conformal radiation, 2) To determine the pattern of relapse in the primary site and neck within the first 2 years following treatment,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage II, III or IV non-metastatic histologically confirmed carcinoma of the head and neck region (Oral cavity, pharynx or larynx). 2. Treatment with radical radiotherapy with or without chemotherapy 3. Patients in whom definitive radiotherapy with or without planned neck dissection is the selected curative treatment 4. ECOG performance status of 0, 1 or 2 Exclusion Criteria: 1. Previous radiotherapy to head and neck mucosa 2. Patients with disabling co-morbid conditions, which do not permit effective immobilization 3. Patients with severe trismus, which disallow effective assessment 4. Patients in whom it is deemed necessary to commence enteric nutrition prior to the start of treatment.
References
Publications (0)
Data not yet available