A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)

NCT ID: NCT00886678

Last Updated: 2011-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

patients receiving pemetrexed, carboplatin and radiation therapy.

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

500 mg/m2, IV, q 21 days x 2 cycles

carboplatin

Intervention Type DRUG

AUC=5,IV,q 21 days x 2 cycles

thoracic radiation

Intervention Type RADIATION

66 Gy over 33 fractions

Interventions

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pemetrexed

500 mg/m2, IV, q 21 days x 2 cycles

Intervention Type DRUG

carboplatin

AUC=5,IV,q 21 days x 2 cycles

Intervention Type DRUG

thoracic radiation

66 Gy over 33 fractions

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhejiang Cancer Hospital

Principal Investigators

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Ma Sheng lin, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ZhejiangCH01

Identifier Type: -

Identifier Source: org_study_id

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