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A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer


Inclusion Criteria:



- Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)

- Presence of measurable disease by RECIST

- Inoperable stage IIIA or IIIB

- ECOG performance status 0-1

- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

- Carcinoid tumor, small cell carcinoma of lung

- Patients with any distant metastasis

- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity
or situation with contraindication for chemotherapy (e.g. active infection,
myocardial infarction preceding 6 months, symptomatic heart disease including
unstable angina, congestive heart failure or uncontrolled arrhythmias,
immunosuppressive treatment)

- Pregnant or lactating women, women who has not taken test of pregnancy (within 14
days before the first administration) and pregnant women

- Women and men of childbearing potential who have no willing of employing adequate
contraception

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor response rate

Outcome Time Frame:

Tumor assessments after completion of chemoradiotherapy and every 2 months

Safety Issue:

No

Principal Investigator

Ma Sheng lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZhejiangCH01

NCT ID:

NCT00886678

Start Date:

July 2008

Completion Date:

July 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • pemetrexed
  • radiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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