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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Zhejiang Cancer Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT00886678
First received: March 31, 2009
Last updated: February 23, 2011
Last verified: March 2010
  Purpose

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).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: pemetrexed
Drug: carboplatin
Radiation: thoracic radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • tumor response rate [ Time Frame: Tumor assessments after completion of chemoradiotherapy and every 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • the safety profile [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • site of first failure in patients who develop progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients receiving pemetrexed, carboplatin and radiation therapy.
Drug: pemetrexed
500 mg/m2, IV, q 21 days x 2 cycles
Drug: carboplatin
AUC=5,IV,q 21 days x 2 cycles
Radiation: thoracic radiation
66 Gy over 33 fractions

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886678

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Ma Sheng lin, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Ma Shenglin, Xu Yaping, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT00886678     History of Changes
Other Study ID Numbers: ZhejiangCH01
Study First Received: March 31, 2009
Last Updated: February 23, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
Non-Small Cell Lung Cancer
pemetrexed
radiation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 22, 2014