Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy

This study has been terminated.
(this trial enroll extremely slow and No funding support)
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT00745797
First received: September 2, 2008
Last updated: January 27, 2014
Last verified: January 2014
  Purpose
  1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
  2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
  3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).

Condition Intervention Phase
Brain Metastases
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy:A Multi-center Randomized Phase ⅢTrial

Resource links provided by NLM:


Further study details as provided by Chinese Society of Lung Cancer:

Primary Outcome Measures:
  • The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . [ Time Frame: 2.5years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1year survival,overall survival,incidence rate of radioactive brain injured [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: April 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylactic WBRT
Take the whole brain radiotherapy radiotherapy
Radiation: Radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Other Name: Radiotherapy,Dehydration drugs, elevated white blood drugs,
No Intervention: Observer Group
The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.

Detailed Description:
  1. Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
  2. PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
  3. But its impact on overall and disease free survival is uncertain.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
  2. No previous history of radiotherapy and surgery of brain
  3. Agree to radiotherapy
  4. age > 18 and <75 years
  5. ECOG performance status 1 or less
  6. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
  7. Have provided informed consent

Exclusion Criteria:

  1. Seizure cannot be controled by the drugs
  2. Combined with other disease of the brain such as tumour or infarction
  3. Hypersensitivity to MR enhancer
  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: NCT00745797

Locations
China, Guangdong
Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Yi-Long Wu
Investigators
Principal Investigator: WU YI LONG, MD Chinese Society of Lung Cancer
  More Information

No publications provided

Responsible Party: Yi-Long Wu, Professor, director, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT00745797     History of Changes
Other Study ID Numbers: CSLC0801
Study First Received: September 2, 2008
Last Updated: January 27, 2014
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Chinese Society of Lung Cancer:
nonsmall cell lung cancer
brain metastasis
prophylactic cranial irradiation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014