Clinical trial · Interventional
Simultaneous Integrated Boost (SIB)- IMRT
A Dose Escalation Study With Intensity Modulated Radiation Therapy (IMRT) in Moderately Advanced (T2N0, T2N1, T3N0) Squamous Cell Carcinomas (SCC) of the Oropharynx, Larynx and Hypopharynx Using a Simultaneous Integrated Boost (SIB) Approach.
- 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)
The objective of the study is to assess the feasibility of increasing dose of irradiation with IMRT using a SIB approach over 6 weeks. The primary endpoint of the study will be acute toxicity assessed during treatment and during the first 3 months following the completion of radiotherapy The secondary endpoint will include loco-regional control, disease-free survival, survival and late toxicity at 2 years after completion of radiotherapy
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 |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Drug | Radiation Therapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 Patients
- description
- Radiotherapy Patients
- interventionNames
- Drug: Radiotherapy
- type
- NO_INTERVENTION
- label
- Group 2
Primary outcomes (1)
- measure
- acute toxicity
- timeFrame
- during treatment and during the first 3 months following the completion of radiotherapy
- description
- acute toxicity
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years * Patients with squamous cell carcinoma of the oropharynx, hypopharynx and larynx * Stage T2-N0-M0, T2-N1-M0 or T3-N0-M0 * World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 70. * Provision of written informed consent Exclusion Criteria: * Second primary tumor at the time of diagnosis * Previous history of malignant tumor in the last five years except basal cell carcinoma and carcinoma in situ of the cervix * Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy * Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder * Pregnant or lactating women
References
Publications (0)
Data not yet available