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

Primary Purpose

Thyroid Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

Intensity modulated radiation therapy

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid Cancer, Apatinib, Intensity modulated radiation therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib with IMRT

Arm Description

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)

Outcomes

Primary Outcome Measures

Progression Free Survival

The time from date of randomization until date of first documented disease progression or death from any cause

Secondary Outcome Measures

Short-term treatment response rate

Number of participants responded to the therapy according to RECIST 1.1

Overall survival

Overall survival is calculated from randomization to death from any cause.

Time to Response

Time to first response to the therapy according to RECIST 1.1

Duration of Response

Time from the first response to the therapy to disease progression

Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03

Incidence of acute and late toxicity

Full Information

NCT ID

NCT03300765

First Posted

September 26, 2017

Last Updated

September 28, 2017

Sponsor

Xiayun He, MD

1. Study Identification

Unique Protocol Identification Number

NCT03300765

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

July 1, 2019 (Anticipated)

Study Completion Date

May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiayun He, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer

Keywords

Thyroid Cancer, Apatinib, Intensity modulated radiation therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib with IMRT

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

Apatinib will be used as induction therapy in experimental arm.

Intervention Type

Radiation

Intervention Name(s)

Intensity modulated radiation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

The time from date of randomization until date of first documented disease progression or death from any cause

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Short-term treatment response rate

Description

Number of participants responded to the therapy according to RECIST 1.1

Time Frame

Three months after completion of the therapy

Title

Overall survival

Description

Overall survival is calculated from randomization to death from any cause.

Time Frame

3-year

Title

Time to Response

Description

Time to first response to the therapy according to RECIST 1.1

Time Frame

From the initial treatment to first response, up to 3 years

Title

Duration of Response

Description

Time from the first response to the therapy to disease progression

Time Frame

From first response to disease progression, up to 3 years

Title

Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03

Description

Incidence of acute and late toxicity

Time Frame

Time interval from start to 3 months after completion of the therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiayun He, MD,PhD

Phone

+86 13917564793

hexiayun1962@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Fen Xue, MD

Phone

+86 18505123563

xuefen1992@126.com

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiayun He, MD,PhD

Phone

+86 13917564793

12. IPD Sharing Statement

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

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