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A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy
(SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II
non-small cell lung cancer. (Phase I)

- Determine local control and time to local progression in patients treated with this
regimen. (Phase II)

- Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18
(FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control
and time to progression in these patients.

Secondary

- Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to
predict long-term local control and time to progression in these patients.

- Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT,
to predict local control and time to progression in these patients.

- Determine the utility of PET/CT scan data in guiding treatment planning.

- Determine if treatment with radiotherapy involving high biological doses with limited
treatment volume using these SBRT techniques achieves acceptable treatment-related
toxicity.

OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.

- Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3
times within a 2-week time frame.

Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both
phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16
weeks after completion of SBRT.

After completion of study treatment, patients are followed periodically for 4 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage I or II non-small cell lung cancer
meeting the following criteria:

- No bronchoalveolar cell carcinoma

- Maximum T2 or T3 tumor size ≤ 5 cm

- T3 primary tumor must be limited to chest wall

- Primary tumor of any T stage must be within or touching the zone of the trachea
or proximal bronchial tree, defined as a volume of 2 cm in all directions around
the trachea and proximal bronchial tree (carina, right and left main bronchi,
right and left upper lobe bronchi, intermedius bronchi, right middle lobe
bronchus, right and left lower lobe bronchi)

- For lesions inferior to the proximal bronchial tree, the primary tumor must
be within 2 cm of the esophagus

- Patients with N1 (hilar) lymph nodes positive for malignancy based on size,
fludeoxyglucose F 18 (FDG)-PET scan uptake, or biopsy are eligible if the N1
lymph nodes are located such that they are contiguously within the same
stereotactic radiation treatment field as the primary tumor

- Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in
those areas

- Patients with > 1 cm lymph nodes or abnormal FDG-PET scan (including
suspicious but non-diagnostic uptake) are eligible if directed tissue
biopsy of all abnormally identified areas are negative for cancer

- No evidence of distant metastases

- Suspected M1 disease based on pre-treatment PET imaging must be biopsied

- If the biopsy is positive, the patient is ineligible

- If the biopsy is negative and representative of the lesion in question, the
patient is eligible

- If the biopsy is non-diagnostic, consideration should be given to repeat
biopsy

- If the repeat biopsy remains non-diagnostic or a biopsy is not
feasible, then the patient is ineligible

- Technically resectable disease

- Surgery refused or patient deemed medically inoperable due to co-morbid
conditions

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No synchronous primary or invasive malignancy within the past 2 years other than
non-melanomatous skin cancer

- No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chest radiotherapy (lung or mediastinum)

- No other concurrent anticancer therapy, including other radiotherapy, radiofrequency
ablation (or other antineoplastic interventional radiology techniques), chemotherapy,
biological therapy, vaccine therapy, or surgery

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (Phase I)

Safety Issue:

Yes

Principal Investigator

Volker W. Stieber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU-62206

NCT ID:

NCT00471835

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage I non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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