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

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ClinicalTrials.gov Identifier: NCT03258671
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
LuBing, Guizhou Medical University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Drug: EGFR-TK Inhibitor Radiation: Intensity Modulated Radiation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer: Results of a Randomised,Openlabel,Multicentre Study
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mutation+ concurrent
IMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations.
Drug: EGFR-TK Inhibitor
·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;

Radiation: Intensity Modulated Radiation Therapy

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)。

Experimental: Mutation+ concomitant
IMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.
Drug: EGFR-TK Inhibitor
·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;

Radiation: Intensity Modulated Radiation Therapy

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)。




Primary Outcome Measures :
  1. Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients. [ Time Frame: >4 weeks post treatment ]
    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.

  2. Overall survival (OS) [ Time Frame: Up to 5 years ]
    Overall survival is defined as the time interval from date of diagnosis to date of death from any cause

  3. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]

    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



Secondary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: Up to 5 years ]

    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


  2. Disease control rate (DCR) [ Time Frame: Up to 5 years ]

    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.


  3. Adverse events (toxicities) [ Time Frame: Up to 5 years ]
    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.

  4. Local regional progression-free survival(LRPFS) [ Time Frame: Time Frame: Up to 5 years ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

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

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258671


Contacts
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Contact: Lu Bing, Director 86-18275356814 ouyangww103173@163.com

Locations
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China, Guizhou
The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, China, 550004
Contact: Lu Bing, MD    86-18275356814    ouyangww103173@163.com   
Sponsors and Collaborators
LuBing
Investigators
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Study Director: Lu Bing, Director ouyangww103173@163.com
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Responsible Party: LuBing, Director, Guizhou Medical University
ClinicalTrials.gov Identifier: NCT03258671    
Other Study ID Numbers: CSWOG
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms