Clinical trial · Interventional
To Study the Impact of Radiation Treatment After Surgery in Patient With Locally Advanced Thyroid Cancer.
Phase II Randomized Controlled Trial Of Postoperative Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Thyroid Cancers.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Toxicity | — | UNRESOLVED | — |
| Thyroid Cancer Stage IV | Malignant Thyroid Gland Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery alone | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intensity Modulated radiotherapy
- description
- 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.
- interventionNames
- Radiation: Intensity Modulated Radiotherapy
- Procedure: Surgery alone
- type
- OTHER
- label
- Surgery alone
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available