Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer

NCT07777536 | Recruiting Phase 2

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

Brief Summary

To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer

Conditions

Thyroid Cancer

Keywords

poorly differentiated thyroid cancer; anaplastic thyroid cancer; selective coverage radiotherapy; locoregional control; radiotherapy-related toxicity

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Progression Free Survival，PFS

  12 months

• Overall Survival, OS

  12 months

• Disease Control Rate，DCR

  up to 12 months

• Adverse Events

  12 months

• Quality of Life (QoL) by EORTC QLQ-H&N35 questionnaire.

  12 months

Study Arms (2)

Selective coverage radiotherapy

EXPERIMENTAL

Radiation: Selective coverage radiotherapy

comprehensive coverage radiotherapy

ACTIVE COMPARATOR

Radiation: comprehensive coverage radiotherapy

Interventions

Selective coverage radiotherapy RADIATION

1. 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.

Selective coverage radiotherapy

comprehensive coverage radiotherapy RADIATION

1. 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）.

comprehensive coverage radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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
• expected survival ≥ 3 months
• major organ functions can meet the requirements for radiotherapy and the proposed systemic treatment.
• The subject voluntarily participates in the study and signs a written informed consent form, willing to follow up according to the protocol and fill in the quality of life scale.

You may not qualify if:

• 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.)
• Cannot complete radiotherapy fixation, simulation positioning or follow-up imaging assessment.
• Other situations that the researcher deems unsuitable for participation in this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Carcinoma, Anaplastic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Xiayun He, MD

CONTACT

+86021-64175590-81412; hexiayun1962@163.com

Fen Xue, MD

CONTACT

dr_fenxue@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 20, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2032
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)