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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Radiotherapy

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Radiotherapy, Intensity-Modulated, Dose Fractionation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Cross Cancer Institute

Outcomes

Primary Outcome Measures

Toxicity of treatment

Secondary Outcome Measures

Local control

overall survival

Disease Free Survival

Full Information

NCT ID

NCT00690963

First Posted

June 3, 2008

Last Updated

April 5, 2016

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT00690963

Brief Title

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

Official Title

A Phase I/II Dose Escalation Trial Using Hypofractionation With Individualized Differential Boosting With Respiratory Gated Intensity-modulated Radiation Therapy (IMRT) in the Treatment of Non-small Cell Lung Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

All patients must have a satisfactory IMRT plan prior to starting radiation therapy, which will commence concurrently with chemotherapy. All patients will be treated to a minimum of 48 Gy in 20 daily fractions over 4 weeks [2.4 Gy per fraction (fx)], to the planning target volume (PTV) defined by pre chemotherapy CT with PET imaging. This is approximately biologically equivalent to a dose of 54 Gy in 27# (5 fractions/week). A differential boosting will then be selected from one of 5 dose escalation schemes. The total individual radiotherapy dose will be prescribed according to the highest dose level that can satisfy all of the set radiotherapy planning constraints for the individual's anatomy. The trial will proceed in 2 phases. In the first phase only the first 3 dose escalation schedules will be used. Once all of these 3 schedules have been deemed safe then dose levels 4 and 5 will be opened up to participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Radiotherapy, Intensity-Modulated, Dose Fractionation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Toxicity of treatment

Time Frame

90 days (Acute), 5 years (Late)

Secondary Outcome Measure Information:

Title

Local control

Time Frame

5 years

Title

overall survival

Time Frame

5 years

Title

Disease Free Survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilson Roa, MSc, MD, FRCPC

Organizational Affiliation

Cross Cancer Institute, Alberta Health Services

Official's Role

Study Chair

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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