Apatinib Combined With Radiotherapy in Patient With BM From Drive Gene Negative NSCLC

NCT03801200 | Unknown Phase 2

• 1 other identifier: HBCH RT-2019-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of concurrent radiotherapy with Apatinib in patients with Brain Metastases from drive gene wide-type Non-small-cell Lung Cancer (NSCLC).

Conditions

NSCLC

Keywords

Brain metastasis; Apatinib; Radiotherapy; NSCLC; Drive gene negative

Outcome Measures

Primary Outcomes (1)

• Intracranial progression-free survival (iPFS)

  Defined as the time from randomisation to progression of intracranial disease or death from any cause.

  Evaluated in 24 months since the treatment began

Secondary Outcomes (5)

• Disease control rate (DCR)

  4 weeks after Radiotherapy.

• Objective response rate (ORR)

  4 weeks after Radiotherapy.

• intracranial time to progress (ITTP)

  Tumor assesment at 4 weeks and 12 weeks after radiotherapy, and then every 12 weeks, up to 24 months

• Overall survival (OS)

  Tumor assesment at 4 weeks and 12 weeks after radiotherapy, and then every 12 weeks, up to 24 months

• Rate of Peritumoalbrainedema (PTBE)

  4 weeks after Radiotherapy.

Study Arms (2)

Apatinib combined with Radiotherapy

EXPERIMENTAL

Drugs: Apatinib Apatinib (500 mg/d) was given orally for one week before the brain radiotherapy, and then, continued to be administered at the same way during the brain radiotherapy period (3 weeks). It was given for another one week after the end of the brain radiotherapy. Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy/15 to patients with 1-5 metastatic lesions.

Drug: Apatinib

Radiotherapy alone

NO INTERVENTION

Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy /15 to patients with 1-5 metastatic lesions.

Interventions

Apatinib DRUG

radiotherapy with Apatinib

Also known as: Apatinib Mesylate

Apatinib combined with Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, male or female, signed informed consent;
• Observable imaging data such as CT, MRI, etc., have measurable lesions as defined by RECIST 1.1 (R09-0262);
• ECOG PS score: 0-2;
• Hemogram index: RBC≥3.0×1012/L, WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90g/L
• the expected survival time ≥ 3 months
• Renal function: Cr≤1.2×UNL (upper limit of normal value);
• Liver function: total bilirubin ≤ 1.5 × UNL; ALT, AST ≤ 1.5 × UNL

You may not qualify if:

• Allergies, known to be hypersensitive to any excipients in the study drug. ;
• Patients with recurrent brain metastases have previously received brain radiation therapy
• Patients with high fever and acute infection;
• Patients with active, progressive bleeding or a significant bleeding tendency in the primary lesion;
• Participated in any clinical trial of research drugs within 4 weeks prior to enrollment
• Diarrhea is the main symptom of the important or newly diagnosed acute gastrointestinal diseases, such as Crohn's disease, malabsorption or any cause of CTC ≥ 2 grade diarrhea.
• Current clinically relevant cardiovascular disease or medical history, such as refractory hypertension, NYHA grade 3 congestive heart failure, unstable angina or poorly controlled arrhythmias. Myocardial infarction occurred 6 months before randomization.
• Absolute neutrophil count \<1000/mm3;
• Platelet count \<50000/mm3;
• According to the investigator's point of view, any other serious disease or organ system dysfunction that may affect patient safety or interfere with the safety assessment of the test drug, such as proteinuria (CTCAE4.0-≥3), severe liver and kidney dysfunction (CTCAE4.0-≥3), hand-foot syndrome (CTCAE4.0-≥3) and so on.
• There are ulcers, intestinal perforations, and intestinal obstruction.
• Pregnant and lactating women
• Suspected or indeed have a history of alcohol and drug abuse

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer hospital

Wuhan, Hubei, 430079, China

Location

Related Publications (1)

• Ma J, Pi G, Bi J, Li Y, He H, Li Y, Hu D, Verma V, Han G. Concurrent Apatinib and Brain Radiotherapy in Patients With Brain Metastases From Driver Mutation-negative Non-small-cell Lung Cancer: Study Protocol for an Open-label Randomized Controlled Trial. Clin Lung Cancer. 2021 Mar;22(2):e211-e214. doi: 10.1016/j.cllc.2020.10.007. Epub 2020 Oct 21.

  PMID: 33187916 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Desheng Hu

  Associate dean

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 11, 2019
• Study Start: September 10, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

CN (1)