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Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) Non-Small Cell Lung Cancer


OBJECTIVES:

- Determine the response rate, duration of response, and survival in patients with bulky
stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel,
carboplatin, and radiotherapy followed by surgical resection.

- Assess the toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5
weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the
absence of unacceptable toxicity. At approximately 4 weeks after completion of
chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If
disease is unresectable, patients receive an additional 2 weeks of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer

- Ipsilateral mediastinal node involvement by mediastinoscopy

- No contralateral lymph node involvement

- No malignant pleural effusion

- No distant metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

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

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

- Hemoglobin at least 10 g/dL

Hepatic:

- ALT/AST less than 2 times upper limit of normal

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior malignancy within the past 5 years except adequately treated carcinoma
in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Pathologic response rate as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment

Safety Issue:

No

Principal Investigator

David J. Perry, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington Hospital Center

Authority:

United States: Federal Government

Study ID:

CDR0000068288

NCT ID:

NCT00006469

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237