Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Titre officiel

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Sommaire:

Cet essai de phase III compare l’effet de la chirurgie thoracique ouverte (thoracotomie) à celui de la chirurgie thoracoscopique (chirurgie thoracoscopique assistée par vidéo) dans le traitement des patients atteints d’un ostéosarcome qui s’est propagé aux poumons (métastases pulmonaires). La chirurgie thoracique ouverte est un type de chirurgie pratiquée par une seule incision plus large (comme une grande coupure) entre les côtes, au cours de laquelle on ouvre la poitrine et on retire le cancer. La thoracoscopie est un type de chirurgie thoracique où le médecin pratique plusieurs petites incisions et utilise une petite caméra pour faciliter le retrait du cancer. Cet essai vise à évaluer les deux méthodes chirurgicales différentes pour les patients atteints d’un ostéosarcome qui s’est propagé au poumon, afin de déterminer laquelle est la meilleure.

Description de l'essai

Primary Outcome:

• Thoracic event-free survival (tEFS)

Secondary Outcome:

• Event free survival (EFS)
• Overall survival (OS)
• Post operative pain interference at time point 3, 7-14 days after surgical intervention
• Post operative pain interference at time point 4, 4-6 weeks after surgical intervention

PRIMARY OBJECTIVE:

• To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
  

SECONDARY OBJECTIVES:

• To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
  
• To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma.
• To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.
  

EXPLORATORY OBJECTIVES:

• To compare 30-day rates of perioperative surgical complications for both open surgical resection and thoracoscopy.
• To compare patterns of recurrence (ipsilateral and/or contralateral) in patients who undergo open or thoracoscopic resection for unilateral or bilateral pulmonary metastases.
• To describe the use of localization techniques and its relationship with both surgical approach and pathologic findings.
• To assess the prognostic significance of a decision to change the post-operative treatment plan.
• To describe the relationship between the preoperative chest computed tomography (CT) imaging, intraoperative surgical findings, and pathologic results, comparing radiological features to the presence of viable tumour.
• To prospectively compare between treatment arms the relationship between surgical approach and patient-reported outcomes (PROs), specifically patient functional impairment of the upper extremities, pain intensity, and health-related quality of life (HRQoL).
• To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma.
• To collect and bank pulmonary metastatic lesions (including frozen tissues and paired metastatic lesions coming from the same patient) to facilitate study of metastatic disease and serial blood samples for future tumour profiling, germline and circulating tumour deoxyribonucleic acid (DNA) studies.
  

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM A: Patients undergo open thoracic surgery (thoracotomy).

ARM B: Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery and then every 3 months for up to 2 years.

Voir cet essai sur ClinicalTrials.gov