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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.


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of treatment

Outcome Time Frame:

90 days (Acute), 5 years (Late)

Safety Issue:

Yes

Principal Investigator

Wilson Roa, MSc, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

LU-24123

NCT ID:

NCT00690963

Start Date:

September 2008

Completion Date:

October 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Radiotherapy
  • Intensity-Modulated
  • Dose Fractionation
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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