About this trial
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Pathologically confirmed as ATC, thyroid cancer containing ATC components, PDTC (in accordance with Turin criteria), or other thyroid cancers with poorly differentiated components, and the MDT considers the biological behavior similar to PDTC.
Evaluated by the MDT and proposed to receive external beam radiotherapy, including postoperative R0/R1, R2 gross residual, inoperable local lesion, and local recurrence.
ECOG performance status 0-2
Disqualifiers
Has received radiotherapy to the head and neck or upper mediastinum region in the past, and the target area of this study overlaps significantly with it, and the normal tissue limit cannot be met.
Has severe uncontrolled infections, active bleeding, unaddressed airway crises, severe dysfunction of the heart, lungs, liver, kidneys or other diseases that cannot be safely treated with radiotherapy.
Pregnant or lactating women; women of childbearing age who do not agree to take effective contraceptive measures.
Has other active malignant tumors within 5 years or simultaneously (excluding cured localized tumors such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.)
Trial design
Parallel
Treatments tested in this trial
Selective coverage radiotherapy
Radiation1. GTV or GTV tb 66-70Gy/33-35Fx 2. High-risk CTV 60Gy: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy;The lymphatic drainage areas where the positive lymph nodes are located, can also be regarded as high-risk CTVs according to MDT decision.
comprehensive coverage radiotherapy
Radiation1. GTV or GTV tb 66-70Gy/33-35Fx 2. CTV: Expand the GTV/GTVtb by 10 mm and adjust according to the anatomical barriers, pre-treatment area were involved if received systemic treatment before radiotherapy(60 Gy);prophylactic irradiation was performed on the bilateral neck II-VI regions and upper mediastinum regions based on the extent of lymph node invasion, and the dose was determined according to the risk stratification(54-60Gy).
Treatment groups
Trial outcomes
Primary outcomes
Locoregional control rate,LRC
The time from the randomization date to the first occurrence of locoregional progression/recurrence. Locoregional regions include the primary thyroid lesion or the postoperative tumor bed, the central region/upper mediastinal related regions, the cervical lymph node region, the retropharyngeal lymph nodes, and the cervical soft tissue contiguous with the original lesion. 12-month LRC is defined as 1 minus the cumulative incidence of locoregional progression over 12 months.
Secondary outcomes
Progression Free Survival,PFS
From the date of randomization to the date of the first recording of tumor PD (evaluated according to the RECIST 1.1) or the date of death due to any cause, whichever comes earlier. PD includes local regional recurrence/progression and distant metastasis.
Overall Survival, OS
The time from randomization to death due to any cause.
Disease Control Rate,DCR
Defined as the proportion of patients with a complete response, partial response and stable Disease to radiotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST). Applicable to those with measurable lesions.
Adverse Events
All radiotherapy-related adverse events will be documented
Sponsors and contacts
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