To Study the Impact of Radiation Treatment After Surgery in Patient With Locally Advanced Thyroid Cancer.

Radiation Toxicity Clinical Trial

— THYRO-RT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03669432
• Other study ID #: 1076
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2013
• Est. completion date: July 2026

Study information

• Verified date: April 2022
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Radiation Toxicity
• Thyroid Cancer Stage IV
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
India	Gouri Pantvaidya	Mumbai	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Tata Memorial Hospital	Department of Atomic Energy

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	locoregional recurrence	locoregional recurrence is defined as occurrence of pathology proven recurrence in the neck	after completion of treatment- till 5 years
Secondary	acute toxicity	Acute toxicity will be measured during and after completion of radiation (3 months).	during treatment- till 23 months
Secondary	late toxicity	Late toxicity will be measured using the LENT-SOMA scale	at 2 years after treatment completion