Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Post operative radiotherapy to primary site only: Post operative radiotherapy to primary site only for 6 weeks. No Radiotherapy to the neck.
Control Intervention1: Post operative radiot
Sponsors
NCI AIIMSJhajjar
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 18 or above and less than 70 years 2) Stage pT1-4 histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection. 3) Patient with high risk features: positive or close ( 4) At least one dissected hemi-neck with adequate pathologically lymph node dissection (at least 18 nodes recovered in one dissected hemi-neck) 5) Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC ofthe oral cavity. 6) Karnofskyperformace score greater or equal 70 7) Ability to complete the MD Anderson Dysphagia Inventory (MDADI)and EORTC quality of life questionnaires English or Hindi Version. 8) Timely delivery of PORT preferable within 6weeks of surgery (upto 1-2 weeks of delay beyond 6 weeks is permissible to accommodate for delayed wound healing or other logistics) 9) Written informed consent for treatment. 10) Available to attend long term follow- up
Exclusion criteria
Exclusion criteria: 1) Non squamous histology 2) Presences of distant metastases 3) pT1-2 disease and no high risk features 4) Pathologically N2/N3 disease. 5) Delivery of neo-adjuvant chemotherapy before surgery 6) Patients that require re-irradiation for recurrent disease 7) Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done 8) Initiation of PORT after 8 weeks of radical surgery. 9) Previous radiotherapy to the head and neck region 10) Any invasive malignancy within previous 2 years (other than nonmelanomatous skin carcinoma or cervical carcinoma in situ). 11) Age 70 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in regional control in irradiated versus un-irradiated neck at 2 years.Timepoint: 1. Difference in regional control in irradiated versus un-irradiated neck at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment outcomes loco control, regional control, disease free survival and overall survival as assessed at follow-up visits 3, 6, 12, 18 and 24 months post treatment and then annually until 5 years post treatment 2. Swallowing function, assessed by using the MDADI at baseline, 3, 6, 12, and 24 months. 3. Acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, 18 and 24 months assessed by RTOG & LENT SOMA scale Timepoint: 2 YEARS | — |
Countries
India
Contacts
Public ContactAman Sharma
NCI AIIMS Jhajjar
Outcome results
None listed