Informations générales (source: ClinicalTrials.gov)
ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
août 2018
octobre 2029
13 août 2025
Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid
carcinoma comparing: total thyroidectomy alone (experimental group) versus total
thyroidectomy + Prophylactic Neck Dissection PND (reference group).
Pre-registered patients will be randomized before surgery for tumors with class-6
cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen
section analysis for tumors with class-5 cytology.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Dana HARTL, MD,PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2)
- AND with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary
thyroid carcinoma" (Type 6 according to the Bethesda classification (Appendix
2)
- OR with FNAB cytology "suspicious for malignancy" (Type 5 according to the
Bethesda classification). In this latter case, randomization will be performed
if confirmation of papillary carcinoma on intraoperative frozen section
analysis
2. cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound
performed by the center's designated radiologist according to a standardized report
3. Absence of a medical contra indication to performing a total thyroidectomy with or
without bilateral prophylactic neck dissection of the central compartment
4. Women of childbearing potential should have a negative pregnancy test (serum or
urine) before any radioiodine administration. Sexually active patients must agree to
use an effective method of contraception or to abstain from sexual activity during
the study and for at least 6 months after last dose of radioiodine.
5. Patient affiliated to a social security regimen or beneficiary of such regimen
6. Patients age ≥ 18 years old, french-speaking
7. Patients should understand, sign and date the written informed consent form prior to
any protocol specific procedures. Patients should be able and willing to comply with
study visits.
1. Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2)
- AND with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary
thyroid carcinoma" (Type 6 according to the Bethesda classification (Appendix
2)
- OR with FNAB cytology "suspicious for malignancy" (Type 5 according to the
Bethesda classification). In this latter case, randomization will be performed
if confirmation of papillary carcinoma on intraoperative frozen section
analysis
2. cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound
performed by the center's designated radiologist according to a standardized report
3. Absence of a medical contra indication to performing a total thyroidectomy with or
without bilateral prophylactic neck dissection of the central compartment
4. Women of childbearing potential should have a negative pregnancy test (serum or
urine) before any radioiodine administration. Sexually active patients must agree to
use an effective method of contraception or to abstain from sexual activity during
the study and for at least 6 months after last dose of radioiodine.
5. Patient affiliated to a social security regimen or beneficiary of such regimen
6. Patients age ≥ 18 years old, french-speaking
7. Patients should understand, sign and date the written informed consent form prior to
any protocol specific procedures. Patients should be able and willing to comply with
study visits.
1. Tumors > 40 mm (cT3) or ≤ 10 mm
2. Tumors with extrathyroidal extension suspected or obvious on the pre-operative
work-up or intra-operatively (cT3T4)
3. Metastatic neck lymph nodes or suspicious neck nodes on preoperative ultrasound
(cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle
washout fluid will be performed
4. Metastatic neck lymph nodes found during the thyroidectomy and confirmed with
intra-operative frozen section analysis
5. Medullary thyroid carcinoma on FNAB cytology and/or with basal serum calcitonin >50
pg/ml
6. Preoperative or intra-operative suspicion of non-papillary thyroid carcinoma or
aggressive histopathological subtype or poorly differentiated carcinoma
7. Distant metastases (M1) apparent pre-operatively (found due to symptoms or
fortuitously; no specific pre-operative work-up will be performed, however, in
accordance with current clinical practice)
8. Recurrent nerve paralysis visualized on systematic pre-operative laryngoscopy and/or
abnormal preoperative serum calcium
9. Pregnant or breast feeding women
10. Participation in another therapeutic clinical trial within one year from study entry
11. Patient under guardianship or deprived of his liberty by a judicial or
administrative decision or incapable of giving its consent