Health Condition 1: C040- Malignant neoplasm of anterior floor of mouth Health Condition 2: C039- Malignant neoplasm of gum, unspecified Health Condition 3: C009- Malignant neoplasm of lip, unspecified Health Condition 4: C069- Malignant neoplasm of mouth, unspecified Health Condition 5: C059- Malignant neoplasm of palate, unspecified Health Condition 6: C029- Malignant neoplasm of tongue, unspecified
Conditions
Interventions
Intervention1: Free thyroid lobe transfer: Patients will undergo thyroid lobectomy on the side of the disease and this thyroid lobe will be transferred to the flap donor site and the vessels supplying
Sponsors
Grants not approved so far
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject has a histologically confirmed squamous cell carcinoma of the oral cavity clinically cT3 or cT4. 2. Subject will require free flap reconstruction during primary surgery. 3. ECOG performance status 0 or 1 4. The subject has understood, signed and dated the written informed consent 5. The subject is willing and able to fully participate for the duration of the study 6. Subjects are fit for surgical intervention as determined by the anesthesiologist at Tata medical Center, Kolkata.
Exclusion criteria
Exclusion criteria: 1. The biopsy of the primary disease in the subject is a histology other than squamous cell carcinoma 2. The subject has a synchronous primary located in the upper aerodigestive tract or cancer of any other site 3. Patients with documented hypothyroidism/ hyperthyroidism. 4. Patients having thyroid lesion and/or suspicious nodes in central compartment on imaging. 5. The subject has confirmed metastatic disease at initial clinical evaluation or during investigations 6. The subject is deemed not fit for surgeries due to medical conditions 7. The subject has received any previous surgery, radiotherapy or chemotherapy as treatment for his disease 8. The subject is not fit to receive radiation therapy due to personal choice, logistical reasons, or medical reasons 9. Subjects with past history of psychological illness seriously affecting the subjectâ??s ability to give an informed consent 10. The subject has participated in the study previously and was withdrawn 11. The subject is part of another active clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome to be measured in the study will be number of patients who will be hypothyroid (TSH 5 mU/L)Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures in this study will be the level of TSH in the patients, the radiation parameters such as the technique of irradiation, dose delivered to the thyroid lobe, the stage of the disease.Timepoint: 3 years | — |
Countries
India
Contacts
Public ContactDr Kapila Manikantan
Consultant, department of Head and neck surgery
Outcome results
None listed