Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Arm B Palliative RT 30 Gy in 5 fractions on alternate days: high palliative radiation dose (30 Gy/ 5#/ on alternate days
Control Intervention1: Arm A
Palliative RT 20 Gy in 5 fractions
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: cT4b disease not amenable to surgery in larynx/ Hypopharynx/ Nasopharynx/ Oropharynx/ Oral cavity Histologically proven squamous cell carcinoma Not suitable for curative radiation Non-metastatic disease Age > 18 years and ECOG PS Carotid encasement < 180 degree
Exclusion criteria
Exclusion criteria: Skin ulceration > 2 cm or fistula present Carotid encasement > 180 degree Skull base particularly foramen lacerum involvement Metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare Progression free survival between high palliative radiation dose (30 Gy/ 5#/ on alternate days) versus low palliative dose (20 Gy/ 5#/ 5 days)Timepoint: To compare Progression free survival between high palliative radiation dose (30 Gy/ 5#/ on alternate days) versus low palliative dose (20 Gy/ 5#/ 5 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare acute toxicity between the two radiation doses c) To compare Quality of life between the two arms with QOL ââ?¬â?? HN35 questionnaire d) To correlate effect of radiotherapy on immune function on flow cytometry of peripheral blood mononuclear cells and cytokine levels and survivalTimepoint: QOL every months after RT | — |
Countries
India
Contacts
Public ContactDr Supriya Mallick
AIIMS, New Delhi
Outcome results
None listed