Accelerated Fractionation Radiotherapy (AFRT) Versus Concurrent Chemoradiotherapy (Crt) In Locally Advanced Head And Neck Squamous Cell Carcinoma

All India Institute Of Medical Science (AIIMS)

Status and phase: Unknown; Phase 2

Conditions: HEAD AND NECK CANCER

Treatments: Drug: CISPLATIN; Radiation: EXTERNAL BEAM RADIOTHERAPY

Study type: Interventional

Funder types: Other

Identifiers

NCT01291095

RCTOFAFRTVSCRTINHNSCCAIIMS

Details and patient eligibility

About

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.

Full description

Concurrent chemo-radiotherapy is a common and conventional method of treating locally advanced head and neck squamous cell carcinoma (HNSCC). In locally advanced HNSCC it has been proved to be superior to radiotherapy alone. On the other side accelerated fractionation radiotherapy (AFRT) is a proven practice to improve cure rate in head and neck cancers. Yet it has not been compared with Concurrent Chemoradiotherapy (CRT) in locally advanced HNSCC and hence this study is aiming to compare CRT versus AFRT.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

CONCURRENT CHEMO-RADIOTHERAPY ARM

Active Comparator group

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).

Treatment:

Radiation: EXTERNAL BEAM RADIOTHERAPY

Drug: CISPLATIN

ACCELERATED FRACTIONATION RADIOTHERAPY ARM

Experimental group

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.

Treatment:

Radiation: EXTERNAL BEAM RADIOTHERAPY