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

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ClinicalTrials.gov Identifier: NCT00745797
Recruitment Status : Terminated (this trial enroll extremely slow and No funding support)
First Posted : September 3, 2008
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer

Brief Summary:
  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 or disease Intervention/treatment Phase
Brain Metastases Radiation: Radiotherapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . [ Time Frame: 2.5years ]

Secondary Outcome Measures :
  1. 1year survival,overall survival,incidence rate of radioactive brain injured [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yi-Long Wu, Professor, director, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT00745797     History of Changes
Other Study ID Numbers: CSLC0801
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Yi-Long Wu, Chinese Society of Lung Cancer:
nonsmall cell lung cancer
brain metastasis
prophylactic cranial irradiation

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