Know Cancer

or
forgot password

A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers


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

Thank you

Trial Information

A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers


Inclusion Criteria:



- Histologically confirmed lung cancer, excluding small cell carcinoma

- Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1
andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint
Committee of Cancer criteria 1998

- The primary tumor must be radiographically measurable.

- Age > 18.

- Karnofsky performance status > 70.

- FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion
of the radiation oncologist, usually > 800 ml

- Labs: WBC > 3000; platelet count > 100,000; serum creatinine < 1.5 mg/dl or
creatinine clearance >60 ml/min.

- Laboratory values must be obtained < 3 weeks prior to registration.

- A signed informed consent.

- Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy
to the chest region are eligible as long as the normal tissue tolerance is not
violated by repeat radiotherapy.

Exclusion Criteria:

- Patients with medical contraindication to chemotherapy or radiotherapy.

- Patients with myocardial infarction within the preceding six months or symptomatic
heart disease, including uncontrolled or unstable angina, uncontrolled congestive
heart failure, and uncontrolled arrhythmia.

- Women who are pregnant.

- Patients with small cell carcinoma or mesothelioma

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:

Define the maximum tolerated dose (MTD) using this dose schedule.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Yuhchyau Chen, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtiy of Rochester, Dept of Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

URCC 1597

NCT ID:

NCT00178256

Start Date:

June 1998

Completion Date:

January 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Rochester, Dept. Radiation OncologyRochester, New York  14642