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

NCT03669432 | Active Not Recruiting DMC

• 1 other identifier: 1076
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer Stage IV; Radiation Toxicity

Keywords

locally advanced thyroid cancers, IMRT, toxicity

Outcome Measures

Primary Outcomes (1)

• locoregional recurrence

  locoregional recurrence is defined as occurrence of pathology proven recurrence in the neck

  after completion of treatment- till 5 years

Secondary Outcomes (2)

• acute toxicity

  during treatment- till 23 months

• late toxicity

  at 2 years after treatment completion

Study Arms (2)

Intensity Modulated radiotherapy

EXPERIMENTAL

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; Procedure: Surgery alone

Surgery alone

OTHER

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

Interventions

Intensity Modulated Radiotherapy RADIATION

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.

Intensity Modulated radiotherapy

Surgery alone PROCEDURE

This intervention is of no interest

Intensity Modulated radiotherapy; Surgery alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anaplastic or medullary thyroid cancer
• Previous history of radiation
• Pregnancy
• \< 18 years Patient unwilling to participate in the study.

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Department of Atomic Energy: collaborator

Study Sites (1)

Gouri Pantvaidya

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Radiation Injuries

Interventions

Radiotherapy, Intensity-Modulated; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Assistant surgeon E

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: September 13, 2018
• Study Start: July 1, 2013
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

IN (1)