AzTrials
AzTrials

Non-Small Cell Lung CancerNCT03258671

IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer

A study testing EGFR-TK Inhibitor and Intensity Modulated Radiation Therapy in people with Non-Small Cell Lung Cancer and Nonsmall Cell Lung Cancer, run by LuBing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stage IV non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
EGFR-TK Inhibitor and Intensity Modulated Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 Oct 2017to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed stage IV NSCLC[UICC 2017 8th edition] with known sensitive EGFR mutations(confirmed by tissue or blood).
  • Have not received one or more prior treatments
  • 18 to 80 years of age.ECOG performance status 0～2 or KPS≥60
  • Have distant metastatic lesions≤5；and have clear consciousness when the metastatic sites were brain; and have no influence on pulmonary function when the metastatic sites were lung.
  • Have no contraindications in radiotherapy, EGFR-TKI and chemotherapy
  • Normal bone marrow and organ function as defined below:
Show all 9Show fewer
  • Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 2.0 x IULN AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN; if liver metastases, ≤ 5.0 x IULN Serum creatinine ≤ 1.5 x ULN LVEF ≥ 50% performed no more than 4 weeks prior to enrollment. FEV1>50%，mild-moderate pulmonary function dysfunction.
  • Able to understand and willing to sign a Human Research Protection Office (HRPO) approved written informed consent document (or that of legally authorized representative, if applicable).
  • With good compliance to the treatment and Follow-up

Who cannot join

  • Evidence of small cell, large cell neuroendocrine or carcinoid histology.
  • Non-stage IV NSCLC and ECOG performance status 3～5 or KPS<60
  • Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
  • Malignant pleural effusion and pericardial effusion
  • Uncontrolled intercurrent illness including, but not limited to, hypertension , diabetes mellitus ,ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and/or breastfeeding: Patient must have a negative pregnancy test within 14 days of study entry.
Show all 10Show fewer
  • Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer such as in situ of the cervix. considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to EGFR-TKI or other agents used in the study.
  • With poor compliance
  • The researchers consider it inappropriate to participate in the study

Trial locations and contacts

1 site in 1 country.

Lu Bing, Director contact

86-18275356814

ouyangww103173@163.com

China1 site

  • The affiliated hospital of Guizhou medical university

    Guiyang, Guizhou, 550004

    Lu Bing, MD, 86-18275356814, ouyangww103173@163.com

Other trials in China

About this study

Official title: IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer: Results of a Randomised,Openlabel,Multicentre Study

This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.

In this study, the investigators aim to verify the following hypothesis:

  • whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy, Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung recurring or progressing similarily.
  • Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal tissue dose/volume tolerance than concurrent regimen.
  • the survival can be improved by using this new molecular Target-radiotherapy method.
Being tested
EGFR-TK Inhibitor, Intensity Modulated Radiation Therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGFR-TK InhibitorDrug

    ·EGFR-TKI：gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;

  • Intensity Modulated Radiation TherapyRadiation

    High dose group：DTGTV=70Gy；

    • first course radiotherapy：40Gy/20f/4w（DTPTV：36Gy/20f/4w）,2Gy/f/d；
    • late course radiotherapy：1.5Gy/f、2f/d、interval≥6 hs、DTGTV=30Gy（DTPTV=27Gy）。

    Low dose group：DTGTV=50Gy;

    • first course radiotherapy：32Gy/16f/3w（DTPTV为28.8Gy/16f/3w），2Gy/f/d；
    • late course radiotherapy：1.5Gy/f、2f/d、interval≥6小时、DTGTV为18Gy（DTPTV为16.2Gy）。
Study groups in NCT03258671
Study groupRoleWhat they receive
Mutation+ concurrentExperimentalIMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations.
Receives: Drug: EGFR-TK Inhibitor; Radiation: Intensity Modulated Radiation Therapy
Mutation+ concomitantExperimentalIMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.
Receives: Drug: EGFR-TK Inhibitor; Radiation: Intensity Modulated Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients.

    Tumor Response will be evaluated using the RECIST system. Modified WHO criteria will be used for measurement of tumors. The irradiated lesion will be excluded from the assessment of response.

    Measured: >4 weeks post treatment

  2. Overall survival (OS)

    Overall survival is defined as the time interval from date of diagnosis to date of death from any cause

    Measured: Up to 5 years

  3. Progression-free survival (PFS)

    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

    Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more non-target lesion(s) and/or unequivocal progression of existing non-target lesions

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Objective response rate(ORR)

    Partial response + complete response per RECIST 1.1 criteria Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level

    Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters

    Measured: Up to 5 years

  2. Disease control rate (DCR)

    Percentage of patients who achieve complete response, partial response, or stable disease per RECIST 1.1 criteria.

    Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level

    Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Up to 5 years

  3. Adverse events (toxicities)

    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    Measured: Up to 5 years

  4. Local regional progression-free survival（LRPFS）

    LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first..The target lesions is only for primary tumor and regional positive lymph nodes.

    Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more target lesion(s) and/or unequivocal progression of existing target lesions.

    Measured: Time Frame: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start1 Oct 2017 (estimated)
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03258671
Sponsor's protocol ID
CSWOG
Status last verified
Aug 2017
First submitted
21 Aug 2017
Last updated
25 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li Q, Liang N, Zhang X, Zhang Y, Ouyang W, Su S, Ma Z, Hu Y, Geng Y, Chen X, Lu B. Reasonable Timing of Radiotherapy for Stage IV Non-Small-Cell Lung Cancer During Targeted Therapy Based on Tumour Volume Change. Front Oncol. 2021 Sep 23;11:705303. doi: 10.3389/fonc.2021.705303. eCollection 2021.

    PubMed 34631535

Questions about this trial

What is this clinical trial studying?

A study testing EGFR-TK Inhibitor and Intensity Modulated Radiation Therapy in people with Non-Small Cell Lung Cancer and Nonsmall Cell Lung Cancer, run by LuBing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lu Bing, Director (86-18275356814, ouyangww103173@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients. (time frame: >4 weeks post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03258671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in