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

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ClinicalTrials.gov Identifier: NCT01837745
Recruitment Status : Active, not recruiting
First Posted : April 23, 2013
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE April 16, 2013
First Posted Date  ICMJE April 23, 2013
Last Update Posted Date May 17, 2023
Actual Study Start Date  ICMJE May 13, 2013
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)		 Rate of patient without event at 3 years following randomization [ Time Frame: assessed up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)		 Rate of patient without event during the 3 years following surgery [ Time Frame: assessed up to 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2023)
  • Lachrymal and Salivary Glands Toxicities [ Time Frame: Assessed up at baseline, 2 months, 10 months and 3 years after randomization ]
  • Patient's quality of life, anxiety and fear of recurrence [ Time Frame: at inclusion, 2 months after inclusion, 10 months and 3 years after randomization ]
  • Rate of patients without event [ Time Frame: at 5 years following randomization ]
  • Rate of events adjusted on the initial lymph node status [ Time Frame: at 3 and 5 years following randomization ]
  • Recurrence rate (histologically proven) [ Time Frame: at 3 years following randomization and then at 5 years ]
  • Rate of cure after an event [ Time Frame: at 5 years after randomization ]
  • Cost of treatment and follow-up [ Time Frame: at 3 years after randomization ]
  • Rate of events adjusted on tumoral molecular characterization [ Time Frame: 3 and 5 years after randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
  • Lachrymal Glands Toxicities [ Time Frame: Assessed up to 3 years ]
  • Impact of patient quality of life [ Time Frame: Assessed up at inclusion, 3 months after inclusion, 1 and 3 year post-operatively ]
  • Salivery Glands Toxicity [ Time Frame: Assessed up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Official Title  ICMJE Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Low Risk Differentiated Thyroid Cancer
Intervention  ICMJE
  • Drug: rhTSH stimulation
    Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
    Other Name: 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
    • 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    • 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    • 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
Study Arms  ICMJE
  • 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
      • 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
      • 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
      • 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
    Interventions:
    • Drug: rhTSH stimulation
    • Drug: I131
    • Other: Follow up
  • 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.
    Intervention: Other: Follow up
Publications * Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. doi: 10.1056/NEJMoa2111953.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 5, 2021)		 776
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2013)		 750
Estimated Study Completion Date  ICMJE January 1, 2030
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837745
Other Study ID Numbers  ICMJE 2012-A01569-34
2012/1913 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP