Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer

Conditions

• Recurrent Thyroid Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI) — COMBINATION_PRODUCT
  To safely administer a minimum cumulative dose of external beam radiation to up 3 index tumors per patient, supplemented radiation dose delivered by radioactive iodine (RAI)

Study Details

The goal of this study is to evaluate combined radioactive iodine (RAI, 131-I) and external beam radiotherapy (XRT) to optimize the radiation dose delivered to treat well differentiated thyroid cancers (DTC) with iodine-avid metastases. The investigators hypothesize that precise dosimetric planning will permit this combined RAI-XRT radiotherapeutic approach to be safe and permit higher tumor radiation doses than could otherwise be delivered. Patients with metastatic well-differentiated DTC) that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases, are the target study population. The primary objective is to evaluate safety as defined by the incidence of maximum grade 3 or greater NCI CTCAE toxicity observed during the treatment period and for the first 30 days following completion of radiotherapy. Secondary endpoints will evaluate efficacy at 6 months and feasibility of this combination to deliver a minimum cumulative dose of 80 Gy to the index tumors selected prior to treatment initiation. The investigators plan to enroll 48 subjects at an accrual rate of 1 subject per month over a study duration of 4 years.

Key Dates

Start date

Mar 17, 2021

Status verified

Jun 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2030

Study Design

Enrollment

48 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: High-risk thyroid cancer patients
  All study patients will have histologically confirmed recurrence of thyroid cancer that is incompletely responsive to initial surgery.

Primary Outcome Measure

Safety of combined therapy of XRT plus RAI measured by NCI-CTCAE toxicity [ Time Frame: During external beam radiation therapy (over a 2 week period) ]

Central Contacts

• Dana B. Kaplin, MPH
  410-614-3950
  [email protected]
• Harry Quon, MD
  410-502-3877
  [email protected]

Locations (1)

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