Individual Boosting in Non-Small Cell Lung Cancer Using Hypofractionation, Intensity-modulated Radiation Therapy and Respiratory Gating

NCT00690963 | Unknown Phase 1 DMC

• 1 other identifier: LU-24123
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have inoperable non-small cell lung cancer are presently treated with chemotherapy and radiation therapy. Despite this combined approach, the vast majority of patients will have their cancer recur after treatment. A recurrence is not curable at this time. Because of the sensitivity of surrounding structures to chest irradiation, it has not been possible to give radiation doses that can cure many of these tumors. Intensity-modulated radiation therapy is a special form of radiotherapy delivery that allows doctors to reduce the amount of radiation dose to normal tissues and therefore reduce side effects. The reduction of radiation side effects may allow more radiation to be delivered to tumors, therefore improving tumor control and possibly longevity of patients. The purpose of this study is to determine whether the combination of custom designed intensity-modulated radiotherapy (based on individual tumor anatomy) with regular chemotherapy, will be safe enough to allow further intensification of radiation treatment.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Radiotherapy; Intensity-Modulated; Dose Fractionation

Outcome Measures

Primary Outcomes (1)

• Toxicity of treatment

  90 days (Acute), 5 years (Late)

Secondary Outcomes (3)

• Local control

  5 years

• overall survival

  5 years

• Disease Free Survival

  5 years

Interventions

Radiotherapy PROCEDURE

Dose excalation based on normal tissue toxicity using 5 dose bins ranging from 56.8 Gy/ 27 fractions to 67.3 Gy in 27 fractions.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histologic types: Squamous cell carcinoma, Adenocarcinoma, Undifferentiated large cell carcinoma, Non-Small cee; not otherwise specified (NOS, diagnosis on cytology alone)
• Patients with AJCC Stage II, IIIA or IIIB if all detectable tumour can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
• Patient must be deemed to be suitable to undergo definitive chemo-radiotherapy by the treating Physician.
• Age \> = 18
• ECOG/Zubrod status 0-1
• Patients must have measurable disease on CT imaging
• Satisfactory granulocytes, platelets, bilirubin, AST and calculated creatinine clearance
• Dose volume constraints must be met
• Patient must be able to use the breath-held technique

You may not qualify if:

• Patients who have undergone complete or subtotal tumour resection
• Patients with post-resection intrathoracic tumour recurrence
• Patients eligible for definitive surgery
• Evidence of any small cell histology
• Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
• Exudative pleural effusion, or pleural effusions with positive cytology. Minimal pleural effusions which are too small to safely tap (i.e. not visible on chest x-ray) are eligible.
• Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias
• Pregnant women are ineligible. Patients with childbearing potential must practice appropriate contraception
• Patients with FEV1 \<= 0.8. Patients with FEV1 \>0.8 and \<1.0 to be discussed with a Respiratory Physician

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wilson Roa, MSc, MD, FRCPC

  Cross Cancer Institute, Alberta Health Services

  STUDY CHAIR

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: June 3, 2008
• First Posted: June 5, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

CA (1)