Clinical trial · Interventional
Accelerated Fractionation Radiotherapy (AFRT) Versus Concurrent Chemoradiotherapy (Crt) In Locally Advanced Head And Neck Squamous Cell Carcinoma
Phase II Randomized Controlled Trial of Accelerated Fractionation Radiotherapy (6 Fractions Per Week) Versus Concurrent Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT01291095CI-TRIAL-00004503unknownPhase 2ClinicalTrials.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)
The aim of this trial is to compare the accelerated fractionation radiotherapy and concurrent chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma patients in terms of loco-regional control, toxicities and quality of life.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CISPLATIN | Drug | Cisplatin | ALIAS |
| EXTERNAL BEAM RADIOTHERAPY | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CONCURRENT CHEMO-RADIOTHERAPY ARM
- description
- Patients assigned to CRT arm will be given radiation one fraction per day, on five consecutive days from Monday to Friday along with intravenous cisplatin 40 mg/m2 weekly for seven doses (a minimum of 5weekly chemotherapy).
- interventionNames
- Drug: CISPLATIN
- Radiation: EXTERNAL BEAM RADIOTHERAPY
- type
- EXPERIMENTAL
- label
- ACCELERATED FRACTIONATION RADIOTHERAPY ARM
- description
- Patients assigned to AFRT arm will undergo radiation similarly one fraction per day and then the sixth fraction will be given on another day (Saturday) or as an extra fraction on one of the first five days, but always allowing at least a 6-hour interval between fractions on same day. If any unintended interruption of the treatment occurs, this missing treatment will be given as soon as possible, preferably within a week, but not allowing more than 14 Gy to be given during any 7-day period.
- interventionNames
- Radiation: EXTERNAL BEAM RADIOTHERAPY
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 20 - 60 years old 2. Karnofsky performance scale score 70 or above 3. Biopsy proven squamous cell carcinomas (SCC) of oropharynx, larynx and hypopharynx 4. TNM stages- Stage III -IVB 5. Informed consent (in prescribed form under institutional guidelines) Exclusion Criteria: 1. Lack of histopathological proof of malignancy (HNSCC) 2. Doubtful follow-up and/ or non-compliance 3. Previous oncologic therapy with surgery, radiotherapy or chemotherapy 4. Uncontrolled comorbid conditions e.g hypertension, diabetes mellitus, chronic obstructive pulmonary disease, coronary artery disease
References
Publications (0)
Data not yet available
No reference posted for this study.