DRKS00010244
Recruiting
Phase 1
Dose-intensified neoadjuvant radiochemotherapy for operable locally advanced NSCLC Stage III A & B - NEOAHA-I
niversitätsklinikum Essen0 sites35 target enrollmentApril 4, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nonsmall-cell lung cancer (NSCLC)
- Sponsor
- niversitätsklinikum Essen
- Enrollment
- 35
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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).
Outcomes
Primary Outcomes
Not specified
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