Clinical trial · Observational
Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
- 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)
Phase II and III studies have demonstrated IMRT to be safe and standard practice for head and neck cancers treated with radiotherapy. This study will be an extension to an earlier, in-house, trial to allow continued recording of toxicities and outcomes in patients receiving IMRT for head and neck cancers. This study will allow us to examine radiobiological modelling for normal tissue complication probability and in particular, determining the dose threshold for parotid glands. Our primary objective is to assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toxicity and outcome measures of IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single cohort
- interventionNames
- Radiation: Toxicity and outcome measures of IMRT
Primary outcomes (1)
- measure
- To assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands
- timeFrame
- 5 years
Secondary outcomes (6)
- measure
- To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia)
- timeFrame
- 5 years
- measure
- Overall survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell cancer or undifferentiated cancer of nasopharynx, oropharynx, larynx and hypopharynx and squamous cell carcinoma unknown primary. * TNM Stage: T1-4, N0-3 M0 * Patients requiring primary or postoperative radiotherapy to the primary site and bilateral neck irradiation requiring IMRT * Parotid sparing IMRT feasible (parotids clear of malignant disease) * WHO Performance status 0-1 (Karnofsky \>80) * Aged 18 or older * Induction chemotherapy and concomitant platinum based chemotherapy is permitted * Concomitant cetuximab is permitted where platinum chemotherapy is contraindicated * All patients must be suitable to attend regular follow-up and salivary flow measurements and be available for long term follow up. * All patients must be able to complete self-assessed quality of life questionnaire * Be able to provide written informed consent Exclusion Criteria: * Previous radiotherapy to the parotid gland/s * Pre-existing salivary gland pathology interfering with saliva production * Previous or concurrent illness which in the investigator's opinion which will interfere with either completion of therapy or follow up * Brachytherapy is not allowed as part of the treatment * Presence of lymphadenopathy adjacent to or involving both parotid glands making whole parotid sparing or superficial parotid sparing impossible * Prophylactic use of amifostine or pilocarpine is not allowed
References
Publications (0)
Data not yet available