Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03300765
• Other study ID #: HN-Shanghai
• Status: Recruiting
• Phase: Phase 2
• First received: September 26, 2017
• Last updated: September 28, 2017
• Start date: July 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2017
• Source: Fudan University
• Contact: Xiayun He, MD,PhD
• Phone: +86 13917564793
• Email: hexiayun1962[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

• Aged = 18 years old;

• Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease =10mm according to RECIST 1.1);

• ECOG0-2;

• Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N = 1500/mm^3; PLT = 80,000/mm^3; HB=90g/L;total bilirubin < 1.25ULN; AST/ALT < 2.5 ULN or < 5 ULN with metastasis; SCr =1ULN; CCR > 50ml/min;

• The survival period is expected to be greater than 3 months;

• Willing to accept adequate contraception for patients with childbearing potential.

Exclusion Criteria:

• Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;

• Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;

• Allergic to apainib;

• Uncontrolled high blood pressure and heart disease;

• Patients with gastrointestinal bleeding risk;

• Coagulation disorders(INR>1.5×ULNAPTT>1.5×ULN);

• Uroprotein positive (Uroprotein=2+ or 24-hour urinary protein quantity >1.0g);

• Pregnant or lactating women.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Apatinib
Apatinib will be used as induction therapy in experimental arm.

Radiation:
• Intensity modulated radiation therapy
Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiayun He, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	The time from date of randomization until date of first documented disease progression or death from any cause	3-year
Secondary	Short-term treatment response rate	Number of participants responded to the therapy according to RECIST 1.1	Three months after completion of the therapy
Secondary	Overall survival	Overall survival is calculated from randomization to death from any cause.	3-year
Secondary	Time to Response	Time to first response to the therapy according to RECIST 1.1	From the initial treatment to first response, up to 3 years
Secondary	Duration of Response	Time from the first response to the therapy to disease progression	From first response to disease progression, up to 3 years
Secondary	Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03	Incidence of acute and late toxicity	Time interval from start to 3 months after completion of the therapy