Clincosm LogoSign in Get a demo

ESTIMABL2: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01837745
Collaborator
(none)
776
Enrollment
1
Location
2
Arms
108
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
  • Drug: rhTSH stimulation
  • Drug: I131
  • Other: Follow up
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
776 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Actual Study Start Date :
May 13, 2013
Actual Primary Completion Date :
Mar 31, 2020
Anticipated Study Completion Date :
May 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ablation group

Administration of 1.1 GBq of I131 is given after the second intramuscular injections of rhTSH (0.9 mg). A whole body scan (WBS) is performed 2 to 5 days after the administration or I131 with determination of the neck uptake. Follow-up consists in: 10 (+/- 2 months) after randomization: neck ultrasound + a serum Tg measurement after rhTSH stimulation 2 years (+/- 2 months) after randomization: serum Tg measurement under LT4 treatment (Tg/LT4) 3 years (+/- 2 months) after randomization: neck ultrasound and a serum Tg/LT4 4 years (+/- 2 months) after randomization: a serum Tg/LT4 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

Drug: rhTSH stimulation
Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
Other Names:
  • Thyrogen

    • Drug: I131
    An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.

    Other: Follow up
    10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4) 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 4 years (+/- 2 months) after randomization: a serum Tg/LT4 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    Experimental: Follow up group

    Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation.

    Other: Follow up
    10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4) 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 4 years (+/- 2 months) after randomization: a serum Tg/LT4 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patient without event at 3 years following randomization [assessed up to 3 years]

    Secondary Outcome Measures

    1. Lachrymal and Salivary Glands Toxicities [Assessed up at baseline, 2 months, 10 months and 3 years after randomization]

    2. Patient's quality of life, anxiety and fear of recurrence [at inclusion, 2 months after inclusion, 10 months and 3 years after randomization]

    3. Rate of patients without event [at 5 years following randomization]

    4. Rate of events adjusted on the initial lymph node status [at 3 and 5 years following randomization]

    5. Recurrence rate (histologically proven) [at 3 years following randomization and then at 5 years]

    6. Rate of cure after an event [at 5 years after randomization]

    7. Cost of treatment and follow-up [at 3 years after randomization]

    8. Rate of events adjusted on tumoral molecular characterization [three and five years after randomization,]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. Total thyroidectomy performed 2 to 5 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).

    5. Post-operative neck ultrasound (performed 2 to 5 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 total thyroidectomy less than 2 months or more than 5 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Gustave Roussy Villejuif Val De Marne France 94805

    Sponsors and Collaborators

    • Gustave Roussy, Cancer Campus, Grand Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gustave Roussy, Cancer Campus, Grand Paris
    ClinicalTrials.gov Identifier:
    NCT01837745
    Other Study ID Numbers:
    • 2012-A01569-34
    • 2012/1913
    First Posted:
    Apr 23, 2013
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Thyroid Diseases

    Study Results

    No Results Posted as of Dec 13, 2021