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High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

high dose chemoradiotherapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
Age 1 8-75.
Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2.
Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
No prior radiation to the thorax that would overlap with the current treatment field.
Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN.
A signed informed consent must be obtained prior to therapy.
Induction chemotherapy is allowed.
Life expectancy more than 3 months

Exclusion Criteria:

Patients with any component of small cell lung carcinoma are excluded from this study.
Patients with evidence of a malignant pleural or pericardial effusion are excluded.
Prior radiotherapy that would overlap the radiation fields.
Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
Known hypersensitivity to paclitaxel.
Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
Conditions precluding medical follow-up and protocol compliance

Sites / Locations

Shanghai Genernal HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high dose chemoradiotherapy

Arm Description

all eligible patients receive image-guided intensity-modulated radiotherapy 60 Gy in 30 fractions over 6 weeks and concurrent weekly paclitaxel and cisplatin，followed by hyperfractionated intensity-modulated radiotherapy boost to residual metabolic disease concurrent with the same chemotherapy regimen, followed by adjuvant chemotherapy 6 weeks after completion of radiation therapy.

Outcomes

Primary Outcome Measures

overall survival rate

survival time was measured from the date of study enrollment to the date of death or last follow-up

Secondary Outcome Measures

toxicities

Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.

Full Information

NCT ID

NCT03598517

First Posted

July 15, 2018

Last Updated

August 21, 2020

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03598517

Brief Title

High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Official Title

Intensity-modulated Hyperfractionated Radiotherapy Boost to Residual Metabolic Disease Following Standard Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.

Detailed Description

Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

high dose chemoradiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

high dose chemoradiotherapy

Intervention Description

Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation.

Primary Outcome Measure Information:

Title

overall survival rate

Description

survival time was measured from the date of study enrollment to the date of death or last follow-up

Time Frame

2 year

Secondary Outcome Measure Information:

Title

toxicities

Description

Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer. Age 1 8-75. Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2. Stage III ( American Joint Committee on Cancer AJCC, 7th ed.). No prior radiation to the thorax that would overlap with the current treatment field. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN. A signed informed consent must be obtained prior to therapy. Induction chemotherapy is allowed. Life expectancy more than 3 months Exclusion Criteria: Patients with any component of small cell lung carcinoma are excluded from this study. Patients with evidence of a malignant pleural or pericardial effusion are excluded. Prior radiotherapy that would overlap the radiation fields. Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. Known hypersensitivity to paclitaxel. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. Conditions precluding medical follow-up and protocol compliance

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ningning Cheng, MD

Phone

37798364

Ext

8119

ningcnn@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Liu, MD

Phone

37798364

drliuyrt@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tingfeng Chen, MD

Organizational Affiliation

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Genernal Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ningning Cheng

Phone

37798364

Ext

8119

ningcnn@163.com

First Name & Middle Initial & Last Name & Degree

yong Liu

Phone

37798364

Ext

8110

drliuyrt@163.com

12. IPD Sharing Statement

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High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

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