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Completed

NCT Number: NCT00132665

Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)

The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

71 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan

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About this study

The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically and/or cytologically proven NSCLC
  • Unresectable disease
  • Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions
  • A required radiation field of less than one half of one lung
  • Measurable disease
  • No previous chemotherapy or radiotherapy
  • Age >= 71
  • Unable to receive cisplatin-based combination chemotherapy
  • ECOG performance status (PS) of 0-2
  • Adequate bone marrow, lung, hepatic, and renal function
  • Written informed consent

Exclusion criteria

  • Active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, or severe other comorbidity
  • Synchronous cancer or metachronous (within 5 years) malignancy
  • Interstitial pneumonia or active lung fibrosis on chest X-ray
  • Severe chronic obstructive pulmonary disease, chronic bronchitis, or bronchial asthma
  • Pleural or pericardial effusion
  • A history of severe hypersensitivity
  • Mental disorder
  • Judging of inappropriate condition for this study by physician

Treatment and study plan

A: Radiotherapy alone

Procedure

Procedure/Surgery: A: Radiotherapy alone

B: CBDCA and Radiotherapy

Drug

Drug: B: CBDCA and Radiotherapy

Primary outcomes

  1. Overall survival

    Time frame: During the study conduct

Secondary outcomes

  1. Response rate

    Time frame: During the study conduct

  2. Adverse events

    Time frame: During the study conduct

  3. Progression-free survival

    Time frame: During the study conduct

  4. Pattern of progression/relapse

    Time frame: During the study conduct

Sponsors and collaborators

Lead sponsor

Japan Clinical Oncology Group

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer (JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)

Important dates

Study start
2003
Primary completion
2011
Study completion
2012
First posted
Aug 22, 2005
Registry last updated
Dec 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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