Clinical trial · Interventional
A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
NCT03699969CI-TRIAL-00035227unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer
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 |
|---|---|---|---|
| Locally Advanced Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated dose escalated VMAT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated dose escalated VMAT
- description
- Hypofractionated dose escalated VMAT radiotherapy
- interventionNames
- Radiation: Hypofractionated dose escalated VMAT
- type
- NO_INTERVENTION
- label
- Conventional concurrent chemoradiation
- description
- Conventional concurrent chemoradiation
Primary outcomes (1)
- measure
- Local control in the two arms
- timeFrame
- 33 months
- description
- Local control by RECIST criteria
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years and ≤70 years old. 2. Histopathologically confirmed squamous cell carcinoma of head and neck. 3. Locally advanced tumors (T3-T4 \&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition). 4. Patients not exposed to radical surgery for current disease. 5. Performance status (ECOG) 2 or less. 6. No associated co-morbidity with contraindication to chemotherapy. 7. Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L) 8. Accepted renal functions. (BUN \& serum creatinine \<1.5x upper limit of normal value with normal GFR). 9. Accepted liver functions. (total bilirubin and direct bilirubin \< 1.5 x ULN \& alanine aminotransferase and aspartate aminotransferase \< 3 x ULN) 10. Informed consent. Exclusion Criteria: 1. Patients with distant metastatic lesions, as detected by imaging techniques. 2. Patients with history of other head and neck malignancies. 3. Patients with history of previous head and neck irradiation. 4. Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection. 5. Women who are pregnant or breast feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.