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TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)

Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)

Inclusion Criteria:

- Written Informed consent

- Patients >18 years of age, with early stage I-IIIA disease who are eligible for
primary surgery

- Primary surgery in keeping with NICE guidelines (lobectomy (either open or
thoracoscopic), lung parenchymal-sparing operations (segmentectomy or wedge
resection) if a complete resection can be achieved, extensive surgery
(bronchoangioplastic surgery, bilobectomy, pneumonectomy) if necessary to obtain
clear margins, hilar and mediastinal lymph node sampling or en bloc resection)

- Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging
necessitating surgery (e.g. diagnosis determined from frozen section in theatre)

- Agreement to be followed up every 3 months in the first year and then 6 monthly for
cfDNA analysis and chest xray assessments for total 5 years.

- Agreement to be followed up in specialist centre

- Performance status 0 or 1

- Considered sufficiently fit for platinum/vinorelbine adjuvant therapy if indicated
(cisplatin or carboplatin allowed)

Exclusion Criteria:

- Any other current malignancy or malignancy diagnosed or relapsed within the past five
5 years (other than non-melanomatous skin cancer and in situ cervical cancer)

- Psychological condition that would preclude informed consent

- Adjuvant regimen other than platinum/vinorelbine

- Women who are pregnant or lactating

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Intratumour heterogeneity

Outcome Description:

• Define the relationship between intratumour heterogeneity and clinical outcome following surgery and adjuvant therapy (including relationships between intratumour heterogeneity and clinical disease stage and histological subtypes of NSCLC).

Outcome Time Frame:

Year 5

Safety Issue:



United Kingdom: Research Ethics Committee

Study ID:




Start Date:

October 2013

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms