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Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

Information source: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Risk Differentiated Thyroid Cancer

Intervention: rhTSH stimulation (Drug); I131 (Drug); Follow up (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Gustave Roussy, Cancer Campus, Grand Paris

Overall contact:
Sophie LEBOULLEUX, MD, Phone: 0142114257, Ext: +33, Email: sophie.leboulleux@igr.fr

Summary

Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1. 1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group). The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

Clinical Details

Official title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Rate of patient without event at 3 years following randomization

Secondary outcome:

Lachrymal and Salivary Glands Toxicities

Patient's quality of life, anxiety and fear of recurrence

Costs of treatment and follow-up

Rate of patients without event at 5 years following randomization

Rate of patients without event at 3 and 5 years after randomization, according to the initial lymph node status

Recurrence rate (histologically proven) at three years following thyroidectomy

Rate of patients without event at 3 and 5 years after randomization, according to tumoral molecular characterization

Future of patients experiencing en event

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component) 2. Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection 3. Surgery performed 2 to 4 months before inclusion 4. Patients with low risk of recurrence: pT1amN0 or pT1amNx with a sum of the size of the lesions above 1 cm and equal to or less than 2 cm, or pT1bN0 or pT1bNx (TNM 2010 classification). (Patients with less than 6 lymph nodes in the neck dissection will be classified as Nx) 5. Post-operative neck ultrasound (performed 2 to 4 months after surgery) showing the absence of abnormalities in the lateral lymph node compartments, or if abnormalities, no lymph nodes with abnormal cytology and/or thyroglobulin concentration in the aspirate fluid > 10 ng/mL 6. Age >=18 years 7. Performance status of 0 or 1 8. Patients who signed the informed consent 9. Patients who can be followed-up annually during 5 years in order to assess the objectives of the study 10. Women of childbearing age should have a negative pregnancy test before any radioiodine administration 11. Both patients with or without thyroglobulin antibodies are eligible Exclusion Criteria: 1. Patients having undergone less than a total thyroidectomy 2. Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component) 3. Patients having undergone surgery less than 2 months or more than 4 months before inclusion 4. Patients with cancer classified as pT1a unifocal (in which ablation is not necessary), or pT1N1, pT2, pT3, pT4 or N1 (who have a higher risk of recurrence) (classification TNM 2010) 5. Patient with known distant metastasis 6. Abnormal post-operative neck ultrasound of the lateral lymph node compartments 7. Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer) 8. Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks. 9. Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine 10. Pregnant or breast feeding women 11. Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures

Locations and Contacts

Sophie LEBOULLEUX, MD, Phone: 0142114257, Ext: +33, Email: sophie.leboulleux@igr.fr

Institut Gustave Roussy, Villejuif, Val de Marne 94805, France; Recruiting
Sophie LEBOULLEUX, MD, Phone: 0142114257, Ext: +33, Email: sophie.leboulleux@igr.fr
Isabelle BORGET, MD, Phone: 0142114146, Ext: +33, Email: isabelle.borget@igr.fr
Sophie LEBOULLEUX, MD, Principal Investigator
Additional Information

Starting date: April 2013
Last updated: June 26, 2013

Page last updated: August 23, 2015

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