Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis and esophagitis grade II or higher by the use of proton therapy compared to photon radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life, loco-regional control, survival and late radiation induced side effects.

Detailed Description
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Patients in this trial undergo primary radiochemotherapy for locally advanced NSCLC. As early and intermediate late effects of radiotherapy do not only hamper quality of life but can, in the case of radiation induced pneumonitis, be potentially lethal, a reduction of these side effects is desirable. Patients in this trial are 1:1 randomised to intensity modulated radiotherapy with photons or proton therapy. The primary aim of the study is to show a decrease of pneumonitis and or esophagitis grade 2 or higher by proton therapy. The observed incidence of both these side effects is 39% with photon therapy. The estimated incidence with proton therapy is around 12 %. Simultaneous chemotherapy will be applied to current clinical standards.

Official Title
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Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Proton therapy
* Radiation: Photon therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NSCLC (confirmed by cytology or histology) staged UICC IIIA or IIIB or UICC II if the patient declines surgery no distant metastases (M1) patient' age between 18 and 70 years Patient medically suited for primary radiochemotherapy with curative intent signed declaration of informed consent adequate compliance for treatment and clinical follow up adequate contraception during and after therapy if indicated Exclusion Criteria: Participation in other interventional trial T1 or T2 N0 tumours that are candidates for stereotactic radiotherapy relevant neurological or psychiatric disorders that hinder treatment, follow-up or understanding of the procedures pregnant or breastfeeding women prior thoracic radiotherapy history of other malignancies during the last 5 years (exceptions can be made for tumours with excellent outcome) weight loss greater than 15% before therapy serological alterations (liver, kidney) prohibiting application of simultaneous chemotherapy respiratory motion of the tumour > 10 mm (evaluated by 4D CT), also when methods for motion reduction (abdominal compression) are used

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton therapy<br>Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week. | Radiation: Proton therapy<br> <br> |
| Active Comparator: Photon therapy<br>Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy. | Radiation: Photon therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of acute and intermediate radiation induced side effects |  | no later than six months after end of treatment |