Know Cancer

forgot password

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



Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Rapid City Regional Hospital Rapid City, South Dakota  57709
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
University of Texas Medical Branch Galveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
University of California Davis Cancer Center Sacramento, California  95817
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Providence Holy Cross Cancer Center Mission Hills, California  91346-9600
Northeast Georgia Medical Center Gainesville, Georgia  30501
Cancer Center at Ball Memorial Hospital Muncie, Indiana  47303
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Cancer Treatment Center Wooster, Ohio  44691
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Schiffler Cancer Center at Wheeling Hospital Wheeling, West Virginia  26003
Arizona Oncology Services Foundation Phoenix, Arizona  85013
Three Rivers Community Hospital Grants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical Center Medford, Oregon  97504
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Alexian Brothers Radiation Oncology Elk Grove Village, Illinois  60007
Bay Medical Panama City, Florida  32401
Oncology Center at Saint Margaret Mercy Healthcare Center Hammond, Indiana  46320
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
Ocean Medical Center at Meridian Health Brick, New Jersey  08724
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
High Point Regional Hospital High Point, North Carolina  27261
Providence Cancer Center at PMCC Medford, Oregon  97504
Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295