Determination of the toxicity of standard dose cetuximab together with concurrent individualised, isotoxic accelerated radiotherapy and cisplatin - vinorelbine for patients with stage III non-small cell lung cancer (NSCLC): a phase I study.

Completed

• Conditions: Non-small cell lung cancer; 10038666

• Registration Number: NL-OMON35459
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Histologically confirmed non-small cell lung cancer
- Inoperable stage III (UICC 2002; sixth edition) (no pleural effusion)
- WHO performance status 0 or 1
- Less than 10% weight loss in the last 6 months
- Lung function: FEV1 at least 50% and DLCO at least 50% of the predicted value
- No recent severe cardiac disease
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- Life expectancy more than 6 months
- Measurable cancer
- Willing and able to comply with study prescriptions
- 18 years or older
- Not pregant or breast feeding
- Written informed consent
- No previous raditherapy to the chest

Exclusion Criteria

- Not non-small cell lung cancer histology
- Mixed pathology
- History of prior chest radiotherapy
- Recent (<3 months) myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
- Inadequate pulmonary function
- Other active malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The MTD will be reached when in a certain step 2/6 or more patients develop<br /><br>grade 3 or more pneumonitis and / or when 3/6 or more patients develop grade 3<br /><br>or more acute esophagitis and /or when 2/6 patients develop grade 3 or more<br /><br>diarrhea, renal or liver toxicity. In case that 1/6 patients develops G4 skin<br /><br>toxicity and / or G4 neuropathy and / or G5 hematological toxicity, another 6<br /><br>patients will be enrolled at that dose level. If again 1/6 patients develops<br /><br>the latter toxicity, DLT will be reached.<br /><br>Furthermore, the MTD will be reached when at maximum one patient may have an at<br /><br>3 months post-treatment persistent G3 or more other toxicity.<br /><br><br /><br>The decision to move to another dose-level of vinorelbine will be taken when<br /><br>the minimum follow-up of each patient in a particular dose-level will be 3<br /><br>months post-radiation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>. Dysphagia (CTC 3.0) during and after chemo-radiation<br /><br>. Cough (CTC 3.0) during and after chemo-radiation<br /><br>. Dyspnoa (CTC 3.0) during and after chemo-radiation<br /><br>. Skin rash associated with chemo-radiation (CTC 3.0) during and after<br /><br>chemo-radiation<br /><br>. Myelitis (CTC 3.0) after chemo-radiation<br /><br>. Neuropathy (CTC 3.0) during and after chemo-radiation<br /><br>. Neutrophiles (CTC 3.0) during and after chemo-radiation<br /><br>. Platelets (CTC 3.0) during and after chemo-radiation<br /><br>. Hemoglobine (CTC 3.0) during and after chemo-radiation<br /><br>. Diarree (CTC 3.0) tijdens en na chemo-radiation<br /><br>. Renal failure (CTC 3.0) during and after chemo-radiation<br /><br>. Lever dysfunctie (CTC 3.0) tijdens en na chemo-radiation<br /><br>. Tumour response 3 months after end chemo-radiation (FDG-PET-CT scan)<br /><br>. Survival</p><br>