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To Study the Impact of Radiation Treatment After Surgery in Patient With Locally Advanced Thyroid Cancer. (THYRO-RT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669432
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
Department of Atomic Energy
Information provided by (Responsible Party):
Dr. Gouri Pantvaidya, Tata Memorial Hospital

Brief Summary:
This trial deals with cancers of the thyroid gland which are advanced at the local site of thyroid. These cancers are treated with surgery and complete removal of the thyroid gland. But due to advanced nature, there is risk of re-occurrence. Radiotherapy can be used to prevent this re-occurrence. This study attempt to see the effect of radiotherapy in preventing re-occurrence and its side effects in advanced thyroid cancer.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Stage IV Radiation Toxicity Radiation: Intensity Modulated Radiotherapy Procedure: Surgery alone Not Applicable

Detailed Description:

Surgery, when possible offers the best chance of cure for cancer of the thyroid gland. Surgery for thyroid cancer involves removal of the thyroid gland along with removal of the lymph nodes which drain the gland. After surgery most patients will receive radio-iodine treatment to diagnose and treat any spread of the cancer in the body. Most thyroid cancers will have good outcomes with the above mentioned treatment. However, in advanced thyroid cancer there is a higher chance of recurrence even with surgery and radio iodine. Surgery for recurrence of these cancers is very morbid This may entail surgeries which may also involve removing portions of the voice box and food pipe. You may therefore develop and discomfort or inability to eat or speak.

Radiation therapy can be given to the neck along with radio-iodine therapy to decrease these re occurrences of the cancer. A number of studies have shown a benefit with the use of radiation therapy in advanced cases of thyroid cancer. However, the side effects of radiation, if any, have not been well documented. This study is being done to assess the impact of radiation on the outcome of cancer and the exact side effects of radiation therapy. If the side effects are not too many, then radiation therapy can be used to decrease the chances of recurrence in the neck after thyroid.

In this study, patients undergoing total thyroidectomy for thyroid cancer will be assessed for high risk features on the histopathology report and the intra operative findings. Those with advanced thyroid cancer as per the eligibility criteria will be counselled and consented for the study. Those patients willing to participate in the study will be randomised to either receive only surgery and radio-iodine or surgery, radio-iodine and external beam radiation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Controlled Trial Of Postoperative Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Thyroid Cancers.
Study Start Date : July 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Intensity Modulated radiotherapy

In this Arm, after surgery, patient will receive radio-iodine treatment as per guidelines, 6-8 weeks after surgery. The patient will receive adjuvant radiation therapy about 8-10 weeks after completion of initial surgery. The duration of this radiation therapy will be approximately 45 days.

: The goal of the treatment plan would be to encompass the PTV subclinical disease with a dose of 54-60 Gy and the PTV of the gross disease with 70-74 Gy while sparing as much of the aforesaid critical structures as possible.

The maximum permissible point doses to the spinal cord will be limited to 46 Gy. IMRT planning and delivery will be carried out on the Tomotherapy Hi Art System.

Radiation: Intensity Modulated Radiotherapy

The patient will receive adjuvant radiation therapy about 8-10 weeks after completion of initial surgery. The duration of this radiation therapy will be approximately 45 days.

: The goal of the treatment plan would be to encompass the PTV subclinical disease with a dose of 54-60 Gy and the planned target volume (PTV) of the gross disease with 70-74 Gy while sparing as much of the aforesaid critical structures as possible.

The maximum permissible point doses to the spinal cord will be limited to 46 Gy. IMRT planning and delivery will be carried out on the Tomotherapy Hi Art System.


Procedure: Surgery alone
This intervention is of no interest

Surgery alone
In this Arm, after surgery patient will receive radio-iodine treatment as per guidelines, 6-8 weeks after surgery. Patient under surgery arm will receive no further treatment after surgery and radio-iodine therapy and will be kept on a routine follow up
Procedure: Surgery alone
This intervention is of no interest




Primary Outcome Measures :
  1. locoregional recurrence [ Time Frame: after completion of treatment- till 5 years ]
    locoregional recurrence is defined as occurrence of pathology proven recurrence in the neck


Secondary Outcome Measures :
  1. acute toxicity [ Time Frame: during treatment- till 23 months ]
    Acute toxicity will be measured during and after completion of radiation (3 months).

  2. late toxicity [ Time Frame: at 2 years after treatment completion ]
    Late toxicity will be measured using the LENT-SOMA scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A) All patients of differentiated thyroid cancer (papillary/follicular/poorly differentiated/) who have undergone total/completion thyroidectomy at our institute and having at least two of the following features (listed below) intra-operatively and/or on histopathology

  1. Gross extrathyroidal spread into soft tissues of the neck, trachea, esophagus, recurrent laryngeal nerve (constituting stage T4a)
  2. R1/ shave resections (minimal residual disease)
  3. R2 resections (gross residual disease)
  4. Multiple lymph nodes positive(>2) with perinodal extension at level VI B) Normal baseline haematological and biochemical parameters.

Exclusion Criteria:

  1. Anaplastic or medullary thyroid cancer
  2. Previous history of radiation
  3. Pregnancy
  4. < 18 years Patient unwilling to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669432


Contacts
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Contact: Gouri H Pantvaidya, MS +919833971155 docgouri@gmail.com
Contact: Sarbani Ghosh-Laskar, MD 9820834386 sarbanilaskar@gmail.com

Locations
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India
Gouri Pantvaidya Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Gouri Pantvaidya, MS    +919833971155    docgouri@gmail.com   
Principal Investigator: Gouri Pantvaidya, MS         
Principal Investigator: Sarbani GhoshLaskar, MD         
Sub-Investigator: Sandeep Basu, MD         
Sub-Investigator: Anil D'Cruz, MS         
Sponsors and Collaborators
Tata Memorial Hospital
Department of Atomic Energy
  Study Documents (Full-Text)

Documents provided by Dr. Gouri Pantvaidya, Tata Memorial Hospital:
Informed Consent Form  [PDF] May 21, 2015

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Responsible Party: Dr. Gouri Pantvaidya, Associate Professor & Assistant surgeon E, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT03669432    
Other Study ID Numbers: 1076
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Gouri Pantvaidya, Tata Memorial Hospital:
locally advanced thyroid cancers, IMRT, toxicity
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms