Recurrent Thyroid Cancer study: Combination treatment
Official title Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
ClinicalTrials.gov ID: NCT04892303
What this study is testing
What is Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI)?
This is an investigational combination of two types of radiation therapy being studied for recurrent thyroid cancer. It is designed to deliver a higher total radiation dose to specific tumors by combining external beam radiation with radioactive iodine.
Also referred to as radiopharmaceutical (RPT).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if using two types of radiation together is safe and can deliver a strong dose to the cancer.
- Who it's for
- The study is looking for people with thyroid cancer that has spread and cannot be fully removed by surgery.
- What's involved
- Participants will receive radioactive iodine and external beam radiation, along with regular tests to monitor their health.
- Time commitment
- The study lasts about 4 years, with safety checks during treatment and for 30 days after finishing radiation.
- Phase 1: an early, usually small safety study
- Time commitment: about 4 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 18 and 85 years, inclusive.
- Histologically confirmed papillary or follicular thyroid carcinoma, collectively referred to as differentiated thyroid carcinoma (DTC), that is...
- DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases.
- Iodine avid residual disease, but with a sub-therapeutic level of lesional radioiodine uptake demonstrated in either a pre-treatment diagnostic scan...
- Adequate organ function, including: a) adequate renal function, defined as a measured creatinine clearance \>70 ml/min/1.73 m2 or normal radioisotope...
See the full eligibility criteria
- 18 and 85 years, inclusive.
- Histologically confirmed papillary or follicular thyroid carcinoma, collectively referred to as differentiated thyroid carcinoma (DTC), that is incompletely responsive to initial surgery +/- 131-Iodine as established by...
- DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases.
- Iodine avid residual disease, but with a sub-therapeutic level of lesional radioiodine uptake demonstrated in either a pre-treatment diagnostic scan or a previous post-treatment radioiodine scan, making it unlikely that...
- Adequate organ function, including: a) adequate renal function, defined as a measured creatinine clearance \>70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR)
- Life expectancy of at least 8 weeks.
- Karnofsky performance status (KPS) \> 50%
- Patients must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above.
- Patient is pregnant or breastfeeding.
- Patient is sexually active, premenopausal, and does not agree to use accepted, effective forms of contraception.
- Any criteria that would contraindicate radioiodine therapy or external beam radiotherapy.
- Patient having alimentary toxic aleukia (ATA) low and intermediate risk tumors, not meeting the guidelines for either radioactive iodine (RAI) treatment or External beam radiotherapy (EBRT).
- Patient with advanced central nervous system (CNS) metastatic disease, critical lesions in the hip and spine, etc.
- Patients having recent exposure to iodinated contrast (within 6 weeks, that could render RAI treatment ineffective).
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.