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OpenTrials
Completed

NCT Number: NCT00643396

Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.

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Key information

Conditions

Extensive Stage Small Cel Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic or cytologic confirmation of small cell lung cancer
  • extensive stage disease
  • adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)
  • patients of childbearing potential must practice adequate contraception
  • age ≧ 18 years
  • Karnofsky performance status ≧ 70
  • documented objective response to initial chemotherapy
  • signed study-specific informed consent form

Exclusion criteria

  • complete or subtotal tumor resection
  • non-small cell histology
  • prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
  • prior chest or neck RT
  • inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)
  • pregnant

Treatment and study plan

thoracic radiotherapy

Radiation

Primary outcomes

  1. local control

    Time frame: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment

Secondary outcomes

  1. radiotherapy toxicities

    Time frame: 1-2 years after study treatment

  2. patient quality of life

    Time frame: 1-2 years after study treatment

  3. overall survival

    Time frame: 1-2 years after study treatment

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Cross Cancer Institute

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2008
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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