Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer

NCT00126828 | Completed Phase 1

• 2 other identifiers: LU-11-0031 / 17141PCRP-07
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have limited stage small cell lung cancer are presently treated with chemotherapy and radiation therapy (RT). Despite this aggressive treatment the vast majority of patients will have their cancer recur after treatment. A recurrence is not curable at this time, therefore efforts to reduce recurrence rates are desirable. Due to the sensitivity of surrounding structures in the chest to radiation, it has not been possible to give doses that can cure most tumours. Three-dimensional conformal radiotherapy is a special form of radiation therapy that allows doctors to reduce the amount of radiation dose to normal tissues and therefore reduce toxicity and in turn, let them safely increase the dose to tumours. The purpose of this study is to determine whether the combination of three-dimensional conformal radiotherapy and chemotherapy will be a more effective treatment. If the treatment is found to be safe for the first group of patients, then the total radiation dose will be increased for the next group of patients who are treated on this study.

Conditions

Carcinoma, Small Cell

Keywords

radiotherapy, conformal; lung neoplasm; radiotherapy dosage

Outcome Measures

Primary Outcomes (1)

• grade 3 RT toxicity rate

Secondary Outcomes (2)

• disease free

• overall survival

Interventions

External beam radiotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven small cell lung cancer
• Age equal to or greater than 18 years
• Good performance status
• Signed study consent form

You may not qualify if:

• Patients who have undergone resection
• Wrong histology
• Previous thoracic/neck radiotherapy
• Prior chemotherapy
• Previous ME within 6 months
• Pregnant
• Tumour too large to irradiate safely

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Small Cell; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peter Venner, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: January 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 24, 2016

Record last verified: 2011-10

Locations

CA (1)