Randomized open label multicentric phase II trial of Adjuvant RadioChemotherapy, Concurrent versus Sequential, in resected non-small cell lung cancer (NSCLC) patients with mediastinal involvement (pN2). The ARCCS trial.

Phase 1

• Conditions: non small cell lung cancer; MedDRA version: 20.0Level: PTClassification code 10062042Term: Lung neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000364-24-IT
• Lead Sponsor: AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients between the ages of 18 and 75.
Patients with NSCLC with a stologically proven diagnosis.
Clinically non-metastatic patients at a distance (CT or MRI negative for metastases
cerebral, chest CT complete abdomen or PET-CT with 18 fluorine-desoxy-glucose negative for
distant metastasis) before enrollment
Patients undergoing lobectomy or sublobar resection and ilo-medistinic lymphadenectomy.
Patients treated surgically with macroscopically radical resection (R0-R1) with mediastinal lymph node involvement (pN2), any stage of T.
ECOG Performance Status 0-1
No other surgical, chemotherapy or radiotherapy treatments for neoplasia, except of non-melanoma tumors of the skin or in situ tumor of the cervix and other solid tumors
which radical treatment was completed at least three years before it was entered into
study and for which the patient has remained continuously free of disease.
Signature of informed consent.
Possibility of access to follow-up.
Preoperative systemic staging with chest CT, full abdomen CT, brain CT with
contrast medium or alternatively brain NMR without and with contrast medium or PET 18FDG and TC
brain with contrast medium or MRI (performed within 90 days prior to randomization).
Interval between surgery and start of treatment not exceeding 60 days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Metastatic disease for pre-operative investigations.
cN3 finding at pre-surgery staging exams.
Patients undergoing neoadjuvant chemotherapy (pre-surgery).
Respiratory function tests (PFR) with FEV1 <1.5 liters or DLCO <50% predicted.
Chronic hepatic failure in stage B and C according to Child-Pugh classification.
Grade IV kidney failure (creatinine clearance <30 ml / min).
Pregnancy or breastfeeding.
allergy to the study drugs or to the excipients used in them
formulation
One of the following conditions:
- Myocardial infarction in the 12 months prior to randomization
- Severe congestive heart failure (NYHA class III-IV)
- Unstable angina
- Cardiomyopathy in progress
- Ventricular arrhythmia
- Uncontrolled arterial hypertension
- Uncontrolled diabetes
- Serious psychotic disorders in progress
- Severe infection in progress
- Any other serious illness that could interfere with the administration
of the therapy foreseen by the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified