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ATOM_local Ablative Therapy

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ClinicalTrials.gov Identifier: NCT01941654
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Pamela Youde Nethersole Eastern Hospital
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

Brief Summary:
To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.

Condition or disease Intervention/treatment Phase
NSCLC Activating EGFR Mutation Radiation: preemptive local ablative therapy Drug: Oral TKI Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: RT + Oral TKI
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Phase II Study to Determine the Efficacy of Preemptive Local Ablative Therapy to Residual Metabolic Active Oligo-metastases in Those EGFR Mutation Positive Non-small Cell Lung Cancer Patients Who Have Achieved a Good Partial Response With First-line EGFR TKI (ATOM)
Actual Study Start Date : September 18, 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: preemptive local ablative therapy Radiation: preemptive local ablative therapy
Drug: Oral TKI



Primary Outcome Measures :
  1. PFS rate at 1 year [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Progression-free survival [ Time Frame: 2 years ]
  3. radiologic change on PET-CT scan 3 months after SABR [ Time Frame: 3 months ]
  4. Number of Participants with Adverse Events as a Measure of safety [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
  2. Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
  3. Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
  4. Not more than 4 residual metabolic active (SUVmax > 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
  5. The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  7. Age ≥ 18 years
  8. Pleural or pericardial effusion at diagnosis is allowed only if it has resolved on CT scan after 3-month EGFR TKI treatment
  9. Brain metastasis at diagnosis is allowed if it has been treated either surgically or with radiotherapy and there is no radiological progression on follow-up CT scan. The patient is neurologically stable for at least 1 week after cessation of steroid treatment
  10. Adequate organ function as defined by the following criteria:

    1. Serum alanine transaminase ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to liver metastases
    2. Total bilirubin ≤ 1.5 x ULN
    3. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    4. Platelets count ≥ 100 x 109/L
    5. Creatinine clearance > 45ml/min
  11. Written informed consent that is consistent with ICH-GCP guidelines

Exclusion Criteria:

  1. Prior chemotherapy is not allowed except adjuvant chemotherapy for completely resected early staged non-small cell lung cancer and it has been at least 12 months before the start of EGFR TKI treatment
  2. Prior radiotherapy is not allowed except brain irradiation
  3. Leptomeningeal carcinomatosis
  4. Lymphangitis carcinomatosis of lung
  5. Prior or concomitant malignancy at other sites is not allowed except treated non-metastatic non-melanoma skin cancer, ductal carcinoma-in-situ of breast and carcinoma-in-situ of cervix with curative intent
  6. Uncontrolled active infection or medical condition (e.g. uncontrolled hypertension, unstable angina, congestive heart failure [≥ NYHA Class II], uncontrolled arrhythmia, myocardial infarction or cerebrovascular accident within the past 6 month)
  7. Pre-existing interstitial lung disease
  8. Woman of child-bearing potential or male patient is unwilling to use adequate birth control method prior to the study entry, for the duration of study participation and for at least 2 months after the EGFR TKI treatment has ended.
  9. Pregnant and Lactating female patient
  10. Non-compliance to the study procedure

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): NCT01941654


Locations
Hong Kong
Department of Clinical Oncology
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Pamela Youde Nethersole Eastern Hospital
Investigators
Principal Investigator: Kwok Chi LAM, FRCP Prince of Wales Hospital

Responsible Party: CCTU, Comprehensive Cancer Trials Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01941654     History of Changes
Other Study ID Numbers: LUN060
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018