Non-small cell lung cancer
Conditions
Interventions
Upfront resection of the lung tumour
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed NSCLCcT3-4N2 tumors with cavitation of the primary tumor and/or multilevel or bulky N2- cT3-4N3 tumorsMale or female aged aged least 18 yearsThe patient must have an Eastern Cooperative Oncology Group (ECOG)/WHO performance status of 0 or 1A pretreatment PET/CT scan (of the thorax) and an MRI (or CT scan) of the brain is considered standard of care and must be done prior to treatmentPathologically proven NSCLC, staged according to the 8th edition of the AJCC Staging Manual, with a clinical indication for concurrent or sequential CRT (according to current guidelines)Patients should be able to receive concurrent or sequential chemoradiotherapyPatients should be operable to the discretion of the treating pulmonary physician, surgeon and anesthesiologist, based on lung function testing and performance scoringEGFR/ALK mutations and never-smokers may be included in the study since endpoints are settled after finishing chemoradiotherapy and before starting adjuvant systemic treatment Pathologically proven N2 or N3 lymph node metastasis, or a high suspicion of presence of N2 or N3 lymph node metastasis, based on diagnostic tests and the expert opinion formulated in a multidisciplinary team meeting. When the patient is considered for inclusion without pathology proven N2 or N3 lymph node metastasis, it must be decided that CRT and adjuvant systemic treatment is the optimal treatment plan for that patient during the multidisciplinary team meetingPatients with a second smaller tumor nodulus within the same lobe may be included as long as stage T3-4 is confirmed based on the primary tumor size and/or cavitation.
Exclusion criteria
Exclusion criteria: Pneumonectomy deemed necessary (by the treating surgeon) to achieve a complete resection (R0)Sulcus superior tumor with invasion of the thoracic wallcT3-4 based on satellite nodus/lesion in the ipsilateral lungPatients with a locoregional recurrence or a secondary primary cancerSmall cell lung cancer or a pulmonary carcinoid tumorPatients who are pregnant or breastfeedingIrresectable primary lung tumor before the start of treatment. When resectability is questionable based on diagnostic tests, one of the participating centers must be consulted regarding resectability of the tumor before patient inclusion. If irresectability is established during surgery, the treatment will be considered a failure regarding feasibility. Patients who underwent prior high-dose radiotherapy, significantly overlapping with the current PTV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility as assessed by the number of patients completing the predefined treatment protocol (upfront resection + cCRT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (according to CTCAE version 5.0)Complications (according to the standardized Clavien-Dindo classification of surgical complications) will be registered | — |
Countries
Netherlands
Contacts
Public ContactKoen Hartemink
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed