NCT03099577

Brief Summary

The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

May 3, 2019

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

March 28, 2017

Last Update Submit

May 1, 2019

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity

    1 year

Secondary Outcomes (1)

  • Time to Local Failure

    2 years

Study Arms (7)

radiochemotherapy 1

EXPERIMENTAL

Patients will be treated with radiation therapy 64.8 Gy

Radiation: radiochemotherapy 1

radiochemotherapy 2

EXPERIMENTAL

Patients will be treated with radiation therapy 69.6 Gy

Radiation: radiochemotherapy 2

radiochemotherapy 3

EXPERIMENTAL

Patients will be treated with radiation therapy 74.4 Gy

Radiation: radiochemotherapy 3

radiochemotherapy 4

EXPERIMENTAL

Patients will be treated with radiation therapy 79.2 Gy

Radiation: radiochemotherapy 4

radiochemotherapy 5

EXPERIMENTAL

Patients will be treated with radiation therapy 84 Gy

Radiation: radiochemotherapy 5

radiochemotherapy 6

EXPERIMENTAL

Patients will be treated with radiation therapy 88.8 Gy

Radiation: radiochemotherapy 6

radiochemotherapy 7

EXPERIMENTAL

Patients will be treated with radiation therapy 93.6 Gy

Radiation: radiochemotherapy 7

Interventions

radiochemotherapy 1RADIATION

concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 1
radiochemotherapy 1
radiochemotherapy 2RADIATION

concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 2
radiochemotherapy 2
radiochemotherapy 3RADIATION

concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 3
radiochemotherapy 3
radiochemotherapy 4RADIATION

concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 4
radiochemotherapy 4
radiochemotherapy 5RADIATION

concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 5
radiochemotherapy 5
radiochemotherapy 6RADIATION

concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 6
radiochemotherapy 6
radiochemotherapy 7RADIATION

concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly

Also known as: concurrent chemoradiotherapy regimen 7
radiochemotherapy 7

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  • Age 1 8-75.
  • Zubrod performance status 0-2.
  • 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.

You may not qualify if:

  • 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.
  • Acquired Immune Deficiency Syndrome.
  • Conditions precluding medical follow-up and protocol compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Ethic Committee of Shanghai General Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tingfeng Chen, MD

    the ethic committee of shanghai genernal hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director,department of radiation

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

January 2, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

May 3, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)