Dose-intensified neoadjuvant radiochemotherapy for operable locally advanced NSCLC Stage III A & B

Phase 1

Recruiting

• Conditions: nonsmall-cell lung cancer (NSCLC); C34; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00010244
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Histopathologically proven non-small cell lung cancer. Biopsy must be taken from either primary tumour or regional lymph node.
• At the time of initial diagnosis before any treatment, patients must be clinical stage IIIA [T1-3 N2, T4 N0-1, all M0] or IIIB [T4 N2, T1-3 N3, all M0, UICC, 7. ed.] with one or more of the following criteria:
• T1-T4 tumour, proven by endoscopy or mediastinoscopy or CT or MRI.
• N2 or N3 mediastinal lymph node involvement, histopathologically or cytopathologically verified by either transbronchial fine-needle aspiration (EBUS-TBNA) or mediastinoscopy. T4 N3 stages are to be excluded (see below).
• For enrollment in Neo1, patients must have been deemed potentially resectable by an interdisciplinary tumour board (comprising medical oncologist, radiation oncologist, thoracic surgeon) within four months before study inclusion.
For enrollment in Def0-3, patients should have been either primarily selected for definitive chemoradiotherapy by the interdisciplinary tumour board or have personally voted against neoadjuvant treatment followed by resection, respectively. Reasons for preference of definitive chemoradiation are: tumour is not resectable with acceptable risk, or the cost-benefit comparison between resection and definitive chemoradiation is worse for surgery.
• 18F-FDG-PET/CT is mandatory before mediastinoscopy and treatment start.
• Brain imaging (MRI or CT) before treatment start is mandatory.
• Patients must at least undergo 2 cycles of the specified induction chemotherapy. Following these, a restaging PET/CT within three weeks of radiotherapy treatment planning is mandatory to exclude distant metastases.
• Patients with chronic obstructive pulmonary disease are eligible.
• Patients must have FEV1 = 1.2 l and no dyspnea or hypoxia = grade 2 (CTC).
• Patients with Acquired Immune Deficiency Syndrome (AIDS) or equivalent immune-compromising diseases are eligible when their condition is stable and they are able to undergo a combined chemoradiotherapy regimen.
• Karnofsky Performance Status 80 - 100% at the time of study inclusion.
• Age = 18 y
• Written informed consent

Exclusion Criteria

• Patients who are not treatable within normal tissue dose-volume constraints of the protocol.
• Any component of small-cell histology.
• Stage T4 N3
• Pleural effusion, larger than minimal or exsudative, or cytologically proven malignant.
• Malignant pericardial effusion
• Distant metastases at initial diagnosis or detected on restaging PET/CT
• acute infection requiring specific treatment > 10 days
• Pregnancy or breast feeding. In women of childbearing potential, pregnancy must be excluded before treatment.
Patients must be willing to use medically acceptable forms of contraception, otherwise will be excluded.
• Other invasive malignancies, except for non-melanomatous skin cancer (controlled for at least 5 years).
• Prior radiotherapy to the region of the study cancer, precluding high-dose irradiation.
• Insufficient patients’ compliance, e.g. due to active psychiatric disorders or language barriers.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity within 120 days after the start of radiotherapy and 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 3 or higher toxicity within 360 days after the start of radiotherapy.<br>Incidence of grade 2 or higher pneumonitis within 360 days after the start of radiotherapy.