NCT00907569

Brief Summary

It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2009

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 22, 2016

Status Verified

September 1, 2011

Enrollment Period

1.8 years

First QC Date

May 20, 2009

Last Update Submit

February 18, 2016

Conditions

Lung NeoplasmSmall Cell Carcinoma

Keywords

Small cell lung cancerradiotherapy dose escalation

Outcome Measures

Primary Outcomes (1)

  • 2-year overall survival

    2011

Secondary Outcomes (2)

  • Quality of life

    2011

  • Patterns of Failure

    2011

Interventions

Hypofractionated Chest RadiotherapyRADIATION

Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.

Eligibility Criteria

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

You may qualify if:

  • limited stage small cell lung cancer
  • adequate pulmonary function test (FEV1 \>1.0 L, DLCO \>50%)
  • signed study consent
  • age at least 18 years
  • Karnofsky performance status as least 70%
  • eligible to receive standard concurrent small cell cancer chemotherapy

You may not qualify if:

  • extensive stage disease
  • mixed non small cell and small cell histology
  • inadequate pulmonary function tests
  • not eligible for concurrent chemotherapy
  • subtotal or total tumor resection
  • previous chest/neck radiotherapy
  • prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
  • pregnant
  • prior chemotherapy for another malignancy
  • patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Small CellSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 22, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 22, 2016

Record last verified: 2011-09

Locations

CA(1)