Hypofractionated Radiotherapy for Small Cell Lung Cancer

NCT00469222 | Completed Phase 1 DMC

• 1 other identifier: LU-11-0072 / 23117
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30-50% of the time. Two factors which can improve control and cure rates for this cancer are increasing the chest radiation dose and minimizing the overall time it takes to complete radiation treatments. One method to achieve both of these goals is to give more radiation each day. This study is meant to study how tolerable and effective it would be to increase the intensity of chest radiation for small cell lung cancer patients by increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy that can be safely given with chemotherapy using this strategy. Patients in this trial will be monitored before, during and after their radiation and chemotherapy treatments for treatment side-effects, how effective treatments are at controlling their cancer and quality of life changes. Results from this trial will help to define more effective radiotherapy doses which are tolerable for this type of lung cancer and the quality of life changes patients experience when they undergo these treatments.

Conditions

Lung Neoplasm; Small Cell Carcinoma

Keywords

small cell lung cancer; radiotherapy dose escalation

Outcome Measures

Primary Outcomes (1)

• Rates of acute grade 3 or higher radiotherapy toxicities

Secondary Outcomes (1)

• Overall survival and disease free survival, patient related quality of life

Interventions

hypofractionated external beam PROCEDURE

Eligibility Criteria

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

You may qualify if:

• patients with histologically or cytologically proven newly diagnosed small cell lung cancer
• confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
• adequate pulmonary function tests (FEV-1 \>1.0, DLCO \>50%)
• patients of childbearing potential must practice adequate contraception
• age greater than 18 years
• Karnofsky performance status greater than 70
• adequate hematologic, hepatic and renal function: Hb\>100g/L, WBC \> 4.0x109/L, neutrophils \> 1.0x109/L, platelets \> 100,000x109/L, calculated GFR based on Cockcroft-Gault formula of \>60mL/min (NOTE: for cisplatin, GFR must be above 60ml/min; if less than 60ml/min the patient can not receive cisplatin but could be considered for carboplatin)
• patients must sign a study specific informed consent form

You may not qualify if:

• patient who have undergone complete or subtotal tumour resection
• evidence of non-small cell histology
• pericardial or pleural effusion on radiologic investigations regardless of cytology
• patients cannot be treated with 3DCRT with adherence to the dose volume constraints
• prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
• prior radiotherapy to the thorax or neck
• prior chemotherapy
• patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmias
• compromised lung function with inadequate pulmonary function tests (FEV-1\<1.0, DLCO \<50%)
• pregnancy (patients with childbearing potential must practice appropriate contraception)
• patients who have not had the pre-treatment evaluations outlined in the protocol

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

Lung Neoplasms; Carcinoma, Small Cell; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Don Yee, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 25, 2016

Record last verified: 2012-03

Locations

CA (1)