Free thyroid lobe transfer for prevention of radiation induced hypothyroidism
- Conditions
- Health Condition 1: C040- Malignant neoplasm of anterior floor of mouthHealth Condition 2: C039- Malignant neoplasm of gum, unspecifiedHealth Condition 3: C009- Malignant neoplasm of lip, unspecifiedHealth Condition 4: C069- Malignant neoplasm of mouth, unspecifiedHealth Condition 5: C059- Malignant neoplasm of palate, unspecifiedHealth Condition 6: C029- Malignant neoplasm of tongue, unspecified
- Registration Number
- CTRI/2018/11/016282
- Lead Sponsor
- Grants not approved so far
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 The subject has participated in the study previously and was withdrawn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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method