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A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer

Phase 1/Phase 2
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer


- Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when
administered concurrently with paclitaxel and carboplatin in patients with inoperable
stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of

- Determine the 12-month survival rate in patients treated with this regimen. (Phase II)
(Closed to accrual as of 11/27/07.)

- Determine the toxicity of this regimen in these patients.

- Determine the partial organ tolerance doses for the lung and esophagus in patients
treated with this regimen.

- Determine the complete response rate in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal

- Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal
radiotherapy once daily five days a week for 7-8 weeks. Patients also receive
concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV
over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.

Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy
until the maximum tolerated dose (MTD) is determined when given in combination with
chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients
experience dose-limiting toxicity.

- Phase II: Additional patients are accrued and treated as above at the MTD. At least 3
weeks after completing radiotherapy, patients may receive additional chemotherapy
comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once.
Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3-5 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I [closed to accrual as of
10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.

Inclusion Criteria


- Histologically or cytologically confirmed unresectable stage IIIA or IIIB non-small
cell lung cancer

- Squamous cell carcinoma

- Adenocarcinoma

- Large cell carcinoma

- Non-small cell carcinoma not otherwise specified

- All detectable primary tumor and involved regional lymph nodes must be encompassed by
radiotherapy fields

- Measurable disease on 3-dimensional planning CT scan

- No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma

- No stage IV or recurrent disease

- No distant metastases or supraclavicular lymph node involvement

- No significant atelectasis (i.e., atelectasis of an entire lung)

- No pleural effusions, pericardial effusions, or superior vena cava syndrome

- No lung cancer within the past 2 years

- Ineligible for currently open RTOG phase III lung protocols



- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin less than 1.5 mg/dL

- AST less than 2 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL


- FEV_1 at least 1.0 L


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No weight loss greater than 5% in the past 6 months

- No other malignancy within the past year except nonmelanoma skin cancer


Biologic therapy:

- No prior biologic response modifiers for current lung cancer

- At least 5 years since prior biologic response modifiers


- No prior chemotherapy for current lung cancer

- At least 5 years since prior chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior radiotherapy to the thorax


- No prior complete tumor resection

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Jeffrey Bradley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mallinckrodt Institute of Radiology at Washington University Medical Center


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

Related Keywords:

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



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Providence Holy Cross Cancer CenterMission Hills, California  91346-9600
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Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Three Rivers Community HospitalGrants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical CenterMedford, Oregon  97504
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
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Providence Cancer Center at PMCCMedford, Oregon  97504
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