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

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

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

Study Overview

• Status: Unknown
• Conditions: Thyroid Cancer
• Intervention / Treatment: Drug: Apatinib; Radiation: Intensity modulated radiation therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xiayun He, MD,PhD; Phone Number: +86 13917564793

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib with IMRT; Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	The time from date of randomization until date of first documented disease progression or death from any cause	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is calculated from randomization to death from any cause.	3-year
Short-term treatment response rate	Number of participants responded to the therapy according to RECIST 1.1	Three months after completion of the therapy
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
Duration of Response	Time from the first response to the therapy to disease progression	From first response to disease progression, up to 3 years
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

Collaborators and Investigators

• Sponsor: Xiayun He, MD

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Apatinib; Thyroid Cancer; Intensity modulated radiation therapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: HN-Shanghai

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No