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Trial record 2 of 18 for:    citadel

CIrculating Tumour DNA in Lung Cancer (CITaDeL): Optimizing Sensitivity and Clinical Utility (CITaDeL)

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ClinicalTrials.gov Identifier: NCT03986463
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
This is a prospective observation study in patients with non-small cell lung cancer (NSCLC) starting either cytotoxic chemotherapy or radiation therapy. It will assess changes in circulating tumor DNA (ctDNA) in the days following the initiation of treatment, as well as longitudinal monitoring, to assess the dynamics and value of ctDNA in stage III-IV NSCLC.

Condition or disease Intervention/treatment
Lung Neoplasms Lung Cancer Neoplasm of Lung Non Small Cell Lung Cancer Other: Circulating tumour DNA (ctDNA)

Detailed Description:
The study consists of three cohorts of patients initiating a new treatment for their NSCLC. The cohorts of (1) patients starting concurrent chemotherapy and radiation for stage III NSCLC (2) patients with advanced NSCLC starting cytotoxic chemotherapy (with or without pembrolizumab) (3) patients with advanced NSCLC starting palliative radiation therapy. This study aims to study the changes in ctDNA levels following a new treatment in lung cancer patients and to explore if the diagnostic utility of ctDNA testing is improved immediately following treatment when tumour cells are actively dying. It will also examine the changes in ctDNA levels and mutational analysis longitudinally.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CIrculating Tumour DNA in Lung Cancer (CITaDeL): Optimizing Sensitivity and Clinical Utility
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Cohort 1
  1. Stage III NSCLC as per the American Joint Committee on Cancer 8th edition (AJCC 8th ed.)
  2. Appropriate to undergo concurrent chemotherapy and radiation
  3. Planned radiation dose must be between 54 and 66 Gy
  4. Chemotherapy regimen must include a platinum agent plus one of the following doublet agents: etoposide, pemetrexed, paclitaxel, vinorelbine, docetaxel, gemcitabine or vincristine
  5. Day 1 platinum dose must be ≥ carboplatin 1.6 AUC or cisplatin 30 mg/m2
  6. No prior system chemotherapy (induction) for their stage III NSCLC, any adjuvant chemotherapy given for resected disease must have been at least 100 days prior to enrollment
Other: Circulating tumour DNA (ctDNA)
Circulating tumour DNA (ctDNA) will be isolated from blood samples

Cohort 2
  1. Stage IV NSCLC or stage III NSCLC, as per the AJCC 8th ed.
  2. Planning to start systemic cytotoxic chemotherapy, without concurrent radiation
  3. Previous treatment with tyrosine kinase inhibitors or immunotherapy (PD-1, PD-L1, CTLA4 directed antibodies) is allowed as long as no cytotoxic chemotherapy was given concurrently
  4. Previous palliative radiation is permitted, but must have been completed at least at least 21 days prior to the initiation of treatment
  5. Chemotherapy regimen must include a platinum agent plus one of the following doublet agents: etoposide, pemetrexed, paclitaxel, vinorelbine, docetaxel, gemcitabine or vincristine
  6. Day 1 platinum dose must be ≥ carboplatin 1.6 AUC or cisplatin 30 mg/m2
  7. If cytotoxic chemotherapy was previously given for adjuvant or stage III NSCLC it must have been at least 100 days prior to enrollment
Other: Circulating tumour DNA (ctDNA)
Circulating tumour DNA (ctDNA) will be isolated from blood samples

Cohort 3
  1. Patients with advanced NSCLC set to undergo palliative radiation to the primary or regional or distant metastatic lesion(s), including intracranial lesions
  2. Radiation dose scheduling must be 2.5 to 4.0 Gy on days 1 through 3 for extracranial treatment, ideally 40 Gy in 15 fractions, 20 Gy in 5 fractions, or 30 Gy in 10 fractions.
  3. Radiation dose for brain lesions must be 6 to 9 Gy per dose, ideally 30 to 35 Gy in 5 daily fractions or 27 Gy in 3 fractions on alternating days
  4. No plans for concurrent chemotherapy to be given
  5. Five patients in cohort 3 will receive radiation to the primary tumor and five patients will receive radiation to brain lesions
Other: Circulating tumour DNA (ctDNA)
Circulating tumour DNA (ctDNA) will be isolated from blood samples




Primary Outcome Measures :
  1. To measure the change in quantitative ctDNA levels following the initiation of cytotoxic chemotherapy or radiation [ Time Frame: Cohort 1 and 2: Baseline (pre-treatment) to end of cycle 1 (each cycle is 21 days) of chemotherapy. Cohort 3: Baseline (pre-treatment) to end of radiotherapy (up to 3 weeks) ]
    Post-treatment ctDNA levels will be reported as the mean percent increase with standard deviation at maximum compared to baseline (pre-treatment) ctDNA levels.

  2. To identify the timepoint after the initiation of treatment at which the quantified level of ctDNA peaks [ Time Frame: Cohort 1 and 2: Baseline (pre-treatment) to end of cycle 1 (each cycle is 21 days) of chemotherapy. Cohort 3: Baseline (pre-treatment) to end of radiotherapy (up to 3 weeks) ]
    This will be reported as the mean time to maximal ctDNA level with standard deviation from the initiation of treatment

  3. To detect genetic alterations at the time point of maximal ctDNA that were not present in baseline testing [ Time Frame: Cohort 1 and 2: Baseline (pre-treatment) to end of cycle 1 (each cycle is 21 days) of chemotherapy. Cohort 3: Baseline (pre-treatment) to end of radiotherapy (up to 3 weeks) ]
    Will be reported as gene names, with allelic frequencies, found in post-treatment samples that were not present in samples collected at baseline.


Secondary Outcome Measures :
  1. To identify the proportion of patients that do not have genetic alterations present in baseline samples but have genetic alterations detected at the timepoint of maximal quantified ctDNA [ Time Frame: Cohort 1 and 2: Baseline (pre-treatment) to end of cycle 1 (each cycle is 21 days) of chemotherapy. Cohort 3: Baseline (pre-treatment) to end of radiotherapy (up to 3 weeks) ]
    This will be reported as frequency counts and proportions.

  2. To determine the percentage of stage III patients with clinically relevant (targetable or prognostic), at any stage of lung cancer, ctDNA genetic alterations. [ Time Frame: Cohort 1 and 2: Baseline (pre-treatment) to end of cycle 1 (each cycle is 21 days) of chemotherapy. Cohort 3: Baseline (pre-treatment) to end of radiotherapy (up to 3 weeks) ]
    Will be reported as frequency counts and proportions.


Biospecimen Retention:   Samples With DNA
Circulating tumour DNA (ctDNA) will be isolated from blood samples and stored for potential future testing.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving treatment at the London Regional Cancer Program in London, Ontario, Canada.
Criteria

Inclusion Criteria:

  • Histologically diagnosed NSCLC
  • Age 18 or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • Patients must be able to provide informed consent
  • Patients must meet the criteria above AND fulfill the criteria below for entry into one of the 3 cohorts

Cohort 1

  1. Stage III NSCLC as per the American Joint Committee on Cancer 8th edition (AJCC 8th ed.)
  2. Appropriate to undergo concurrent chemotherapy and radiation
  3. Planned radiation dose must be between 54 and 66 Gy
  4. Chemotherapy regimen must include a platinum agent plus one of the following doublet agents: etoposide, pemetrexed, paclitaxel, vinorelbine, docetaxel, gemcitabine or vincristine
  5. Day 1 platinum dose must be ≥ carboplatin 1.6 AUC or cisplatin 30 mg/m2
  6. No prior system chemotherapy (induction) for their stage III NSCLC, any adjuvant chemotherapy given for resected disease must have been at least 100 days prior to enrollment

Cohort 2

  1. Stage IV NSCLC or stage III NSCLC, as per the AJCC 8th ed.
  2. Planning to start systemic cytotoxic chemotherapy, without concurrent radiation
  3. Previous treatment with tyrosine kinase inhibitors or immunotherapy (PD-1, PD-L1, CTLA4 directed antibodies) is allowed as long as no cytotoxic chemotherapy was given concurrently
  4. Previous palliative radiation is permitted, but must have been completed at least at least 21 days prior to the initiation of treatment
  5. Chemotherapy regimen must include a platinum agent plus one of the following doublet agents: etoposide, pemetrexed, paclitaxel, vinorelbine, docetaxel, gemcitabine or vincristine
  6. Day 1 platinum dose must be ≥ carboplatin 1.6 AUC or cisplatin 30 mg/m2
  7. If cytotoxic chemotherapy was previously given for adjuvant or stage III NSCLC it must have been at least 100 days prior to enrollment

Cohort 3

  1. Patients with advanced NSCLC set to undergo palliative radiation to the primary or regional or distant metastatic lesion(s), including intracranial lesions
  2. Radiation dose scheduling must be 2.5 to 4.0 Gy on days 1 through 3 for extracranial treatment, ideally 40 Gy in 15 fractions, 20 Gy in 5 fractions, or 30 Gy in 10 fractions.
  3. Radiation dose for brain lesions must be 6 to 9 Gy per dose, ideally 30 to 35 Gy in 5 daily fractions or 27 Gy in 3 fractions on alternating days
  4. No plans for concurrent chemotherapy to be given
  5. Five patients in cohort 3 will receive radiation to the primary tumor and five patients will receive radiation to brain lesions

Exclusion Criteria:

  • Any other malignancy in the last five years other than adequately treated non-melanoma skin cancer

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): NCT03986463


Contacts
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Contact: Mark Vincent, MD (519) 685-8500 Mark.Vincent@lhsc.on.ca
Contact: Daniel Breadner, MD (519) 685-8500 Daniel.Breadner@lhsc.on.ca

Locations
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Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Dan Breadner, MD         
Sponsors and Collaborators
Lawson Health Research Institute

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03986463     History of Changes
Other Study ID Numbers: CITaDeL
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases