pfront resection of locally-advanced or cavitating NSCLC followed by chemoradiotherapy (and adjuvant systemic treatment); Phase 1 multicenter study to assess treatment feasibility and safety

• Conditions: Non-small cell lung cancer; 10029107

• Registration Number: NL-OMON53501
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Histologically confirmed NSCLC
- cT3-4N2 tumors with cavitation of the primary tumor and/or multilevel or
bulky N2
- cT3-4N3 tumors
- Male or female aged aged least 18 years
- The patient must have an Eastern Cooperative Oncology Group (ECOG)/WHO
performance status of 0 or 1
- A 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 treatment
- Pathologically 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 chemoradiotherapy
- Patients should be operable to the discretion of the treating pulmonary
physician, surgeon and anesthesiologist, based on lung function testing and
performance scoring
- EGFR/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
meeting

Exclusion Criteria

- Pneumonectomy deemed necessary (by the treating surgeon) to achieve a
complete resection (R0)
- Sulcus superior tumor with invasion of the thoracic wall
- cT3-4 based on satellite nodus/lesion in the ipsilateral lung
- Patients with a locoregional recurrence or a secondary primary cancer
- Small cell lung cancer or a pulmonary carcinoid tumor
- Patients who are pregnant or breastfeeding
-Irresectable 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility as assessed by the number of patients completing the predefined<br /><br>treatment protocol (upfront resection + cCRT)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Safety (according to CTCAE version 5.0)<br /><br>- Complications (according to the standardized Clavien-Dindo classification of<br /><br>surgical complications) will be registered </p><br>