Study to investigate the improvement of chemotherapy in early detected lung cancer after surgery

Phase 1

• Conditions: Patients with pathologically confirmed, R0 resected non-small cell lung cancer (NSCLC), pathologic stage IB, IIA, IIB, T3N1 (without need for further radiotherapy); systematic lymph node dissection is required with resection.; MedDRA version: 15.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-004840-30-DE
• Lead Sponsor: Thoraxklinik Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-04
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC), pathologic stage IB, IIA, IIB or T3N1 (without need for further radiotherapy)

Complete tumor resection without detectable residual tumor including negative margins (R0) [R-classifaction according to Wittekind et al 2002] and systematic intraoperative dissection of mediastinal lymph nodes according to the guidelines of the British thoracic society (British thoracic society, 2001; Hoffmann et al., 1999); of course lymph node dissection has to comprise all lymph node levels removed with standard right or left sided resection. The dissection has to assure the removal of mediastinal lymph nodes > 1,5 cm on the preoperative CT scan.

The following histological tumor types are eligible:
- Squamous Cell Carcinoma
- Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation)
- Large Cell Carcinoma (excluding tumors with slight areas of small cell carcinoma
with neuroendocrine differentiation)
- Mixed Cell Carcinoma without small cell fraction
- Provision of informed consent according to local regulatory requirements for
participation in the study
- Age between 18 – 75 years
- Karnofsky Performance Status = 80% or ECOG performance status less or equal 1
- Adequate hematological laboratory parameters
- Hemoglobin = 10 g/dl
- ANC = 1,500 /µl
- Platelets = 100000 /µl
- Adequate hepatic laboratory parameters:
- Bilirubin less or equal 1.5 x UNL
- ASAT/ALAT less or equal 2 x UNL
- Adequate renal laboratory parameters
- Creatinine less or equal 1,5 mg/dl and
- Calculated Creatinine Clearance = 60 ml/min
- Cardiac function allowing Cisplatin chemotherapy (in case of doubt
echocardiography is mandatory documenting LVEF > 49%)
- 12-lead Electrocardiogram without significant cardiac arrhythmia
- FEV1 = 1.2 l post-operatively
- Respiratory function not impeding Cisplatin-based chemotherapy assessed by
either absolute DLCO or capillary / arterial BGA in resting condition (absolute DLCO
> 40 % or pO2 >60 mmHg in resting condition
- Agreement by the patient to use an effective method of contraception
- Negative pregnancy test for women of childbearing potential or women who are
postmenopausal at baseline. (Postmenopausal women must have been
amenorrheic at least for 12 month to be considered of non child-bearing potential)
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 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 134

Exclusion Criteria

- Presence of a Pancoasttumor
- The following histological tumor types are excluded
- Pure Bronchioloalveolar carcinoma
- Mixed cell carcinoma with small cell fractions
- Large cell carcinoma with areas of small cell carcinoma
- Involvement of N2/N3 lymph nodes
- Distant metastases
- Pregnancy or lactation period
- Other co-existing malignancies or malignancies diagnosed within the last 5 years
with the exception of basal cell carcinoma of cervical cancer in situ or non-
melanomatous skin cancer. Patients curatively treated and free of disease for at
least 5 years will be discussed with the Principal Investigator (LKP) before inclusion
- Radio- and/or chemotherapy within the last five years
- Concurrent administration of any other antitumor therapy
- Patients who are not compliant with vitamin (folic acid and vitamin B12) intake or to
whom administration is not possible
- Treatment with an investigational new drug, currently or within the last 30 days,
and/or participation in another clinical trial, currently or during the last 12 weeks,
and/or previous participation in this study
- Patient has previously completed or withdrawn from this study or any other study
with the respective medication in this study
- History of a psychological illness or condition such as to interfere with the patient's
ability to understand the requirements of the study
- Patients with any clinically significant disease that in the opinion of the investigator
is likely to put the patient at risk or to interfere with the evaluation of the patient's
safety and of the study outcome. This includes, but is not limited to:
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmia not well controlled with medication)
or myocardial infarction within the last 6 months
- Uncontrolled hypertension
- Interstitial pneumonia, or extensive or symptomatic interstitial fibrosis of the lung.
- Pleural effusion or ascites, which cause respiratory compromise. Patients with sero
(pneumo)-thorax after hemi-pneumonectomy will not be excluded. Those patients
must be monitored for toxicity closely.
- Any other active or uncontrolled infection
- Organ allografts
- A serious concomitant systemic disorder (e.g. active infection including HIV) that in
the opinion of the investigator would compromise the patient’s ability to complete
the study
- Post-operative complications or other surgery-related conditions that could
interfere with a study participation
- Patients with neurologic disorders
- A history or presence of any CNS disorder or psychiatric disability judged by the
Investigator to be clinically significant and/or interfering with compliance
- Hearing function/tinnitus impeding chemotherapy with Cisplatin and/or Vinorelbine
- Alcohol and/or drug abuse
- Patient is unable to interrupt high dose salicylates (like aspirin) or other non-
steroidal anti-inflammatory drugs (NSAID´s) for a 5-day period starting 2 days
before administration of Pemetrexed (8-day period for long-acting agents such as
piroxicam).
- Patients who cannot be regularly observed for psychological, sociological,
geographical reasons or other concomitant conditions not permitting adequate
follow-up and compliance to the protocol

Study & Design

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