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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126828
First Posted: August 5, 2005
Last Update Posted: February 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
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.

Condition Intervention Phase
Carcinoma, Small Cell Procedure: External beam radiotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • grade 3 RT toxicity rate

Secondary Outcome Measures:
  • disease free
  • overall survival

Estimated Enrollment: 18
Study Start Date: January 2003
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Radiotherapy represents one of the primary treatment modalities for patients with limited stage small cell lung cancer (SCLC). With contemporary concurrent radiotherapy and chemotherapy, approximately 20% of patients survive 5 years. While distant metastases are common, local (intrathoracic) failures are common as well, occurring in 40% of treated patients. Reducing local failure rates may lead to improved survival for these patients. There appears a growing body of data, which suggests a radiation dose response relationship for SCLC. However, the close proximity of critical normal structures, such as the spinal cord and esophagus, to the primary tumour limits the prescription dose in conventional radiotherapy. Three Dimensional Conformal Radiotherapy (3DCRT) offers the possibility of reducing normal tissue irradiation and hence reducing the treatment toxicity while maintaining the dose of radiation to the tumour. Another strategy is accelerated fractionation, which shortens the treatment time by allowing less opportunity for tumour cell repopulation. The use of 3DCRT with larger radiation fraction size should maintain satisfactory treatment related toxicity while permitting the potential gains of accelerated fractionation and dose escalation. In this study, patients with limited stage SCLC who are eligible will be treated with a large field (low dose) radiotherapy followed by accelerated 3DCRT given concurrently with standard Cisplatin Etoposide chemotherapy.

Primary Objective: To determine the maximum tolerable dose of radiotherapy for SCLC

Secondary Objectives:

  1. To assess treatment toxicity
  2. To assess quality of life and retention of pulmonary function
  3. To assess progression-free survival on this regimen

Schema: Eligible patients will receive 4 cycles of Cisplatin Etoposide chemotherapy. Thoracic radiotherapy will be given concurrently starting with cycle #2 of chemotherapy. Only one dose level will be open at a time. Four dose levels are planned all delivered in 25 fractions once daily over 5 weeks:

  1. 50 Gy (2 Gy per fraction),
  2. 58 Gy,
  3. 62 Gy,
  4. 65 Gy. Patients, who achieve a complete response at the end of chemotherapy and thoracic radiotherapy, will receive prophylactic cranial irradiation.

Evaluation and Follow-up: Patients will be assessed and evaluated at least weekly during radiation therapy. Following treatment, patients will be seen 1 month after the completion of treatment, then every 3 months until 2 years, then every 6 months. Chest x-rays will be performed at each follow-up. CT scan of chest and pulmonary function tests will be performed every 6 months for the first 2 years, then yearly.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126828


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
Principal Investigator: Peter Venner, MD AHS Cancer Control Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00126828     History of Changes
Other Study ID Numbers: LU-11-0031 / 17141
PCRP-07
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: February 24, 2016
Last Verified: October 2011

Keywords provided by AHS Cancer Control Alberta:
radiotherapy, conformal
lung neoplasm
radiotherapy dosage

Additional relevant MeSH terms:
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type