NCT02841228

Brief Summary

Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 5, 2016

Last Update Submit

July 19, 2016

Conditions

Non-Small Cell Lung Cancer

Keywords

SIB-IMRTNSCLCRadiochemothearpy

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    Progression free survival is defined as the time (in months) from the date of admission to the date of progression or last follow-up

    up to 12 months

Secondary Outcomes (3)

  • Treatment-related toxicities

    up to 6 months

  • Overall Response Rate (ORR)

    up to 3 months

  • Overall survival (OS)

    up to 36 months

Study Arms (1)

IMRT + SIB + Chemotherapy

EXPERIMENTAL

For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction, SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

Radiation: IMRT + SIB + Chemotherapy

Interventions

IMRT + SIB + ChemotherapyRADIATION

For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction , SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

IMRT + SIB + Chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
  • Performance status 0 to 2, ≤5% weight loss within the past 6 months
  • A forced expiratory volume at 1 second of ≥ 1 L
  • Life expectancy \> 3 months
  • No invasion of large vessels, heart, esophagus, spinal cord.
  • Based on conformal treatment planning, the volume of lung at or exceeding 20 Gy (V20) must have been≤30%, the mean esophagus dose≤34 Gy, and the volume of esophagus exceeding 55 Gy (V55)≤30%
  • Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
  • Without severe other diseases
  • Informed consent

You may not qualify if:

  • Had received prior thoracic radiotherapy
  • Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome
  • Pregnant and lactating women
  • Serious complications
  • Other primary malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan province tumor pospital

Changsha, Hunan, China

RECRUITING

Related Publications (1)

  • Yang W, Zeng B, Qiu Y, Tan J, Xu S, Cai Y, Zhou Y, Liu Z, Luo J, Wang H. A Dosimetric Comparison of Dose Escalation with Simultaneous Integrated Boost for Locally Advanced Non-Small-Cell Lung Cancer. Biomed Res Int. 2017;2017:9736362. doi: 10.1155/2017/9736362. Epub 2017 May 28.

    PMID: 28630876DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Intensity-ModulatedDrug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of thoracic radiation oncology department

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 22, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2018

Last Updated

July 22, 2016

Record last verified: 2016-07

Locations

CN(1)