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

NCT ID: NCT03258671

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-12-30

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.

Conditions

Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mutation+ concurrent

IMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations.

Group Type: EXPERIMENTAL

EGFR-TK Inhibitor

Intervention Type: DRUG

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

Intensity Modulated Radiation Therapy

Intervention Type: RADIATION

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）。

Mutation+ concomitant

IMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.

Group Type: EXPERIMENTAL

EGFR-TK Inhibitor

Intervention Type: DRUG

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

Intensity Modulated Radiation Therapy

Intervention Type: RADIATION

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）。

Interventions

EGFR-TK Inhibitor

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

Intervention Type: DRUG

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）。

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LuBing

OTHER

Sponsor Role: lead

Responsible Party

LuBing

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lu Bing, Director

Role: STUDY_DIRECTOR

ouyangww103173@163.com

Locations

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, China

Countries

China

Central Contacts

Lu Bing, Director

Role: CONTACT

ouyangww103173@163.com

86-18275356814

Facility Contacts

Lu Bing, MD

Role: primary

ouyangww103173@163.com

86-18275356814

References

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.

Reference Type: DERIVED

PMID: 34631535 (View on PubMed)

Other Identifiers

CSWOG

Identifier Type: -

Identifier Source: org_study_id