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

Phase II Randomized Controlled Trial Of Postoperative Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Thyroid Cancers.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiation Toxicity; Thyroid Cancer Stage IV
• Intervention / Treatment: Radiation: Intensity Modulated Radiotherapy; Procedure: Surgery alone

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Gouri Pantvaidya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
locoregional recurrence	locoregional recurrence is defined as occurrence of pathology proven recurrence in the neck	after completion of treatment- till 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute toxicity	Acute toxicity will be measured during and after completion of radiation (3 months).	during treatment- till 23 months
late toxicity	Late toxicity will be measured using the LENT-SOMA scale	at 2 years after treatment completion

Collaborators and Investigators

• Sponsor: Tata Memorial Hospital
• Collaborators: Department of Atomic Energy

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: locally advanced thyroid cancers, IMRT, toxicity
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: 1076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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