NCT03300765

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 26, 2017

Last Update Submit

September 28, 2017

Conditions

Thyroid Cancer

Keywords

Thyroid CancerApatinibIntensity modulated radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

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

    3-year

Secondary Outcomes (5)

  • Short-term treatment response rate

    Three months after completion of the therapy

  • Overall survival

    3-year

  • Time to Response

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

  • Duration of Response

    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

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

Study Arms (1)

Apatinib with IMRT

EXPERIMENTAL

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: ApatinibRadiation: Intensity modulated radiation therapy

Interventions

ApatinibDRUG

Apatinib will be used as induction therapy in experimental arm.

Apatinib with IMRT
Intensity modulated radiation therapyRADIATION

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

Apatinib with IMRT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

apatinibRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Central Study Contacts

Xiayun He, MD,PhD

CONTACT

+86 13917564793hexiayun1962@163.com

Fen Xue, MD

CONTACT

+86 18505123563xuefen1992@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 3, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

May 1, 2020

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

CN(1)