Clinical trial NCT02731001: Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
Official title: Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
name: National Center for Radiation Research in Oncology Dresden/Heidelberg
First posted: 2016-04-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of acute and intermediate radiation induced side effects
timeFrame: no later than six months after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Radiotherapy and Radiation Oncology
Study officials:
affiliation: Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
name: Esther Troost, Prof.
role: STUDY_CHAIR
References:
citation: Zschaeck S, Simon M, Lock S, Troost EG, Stutzer K, Wohlfahrt P, Appold S, Makocki S, Butof R, Richter C, Baumann M, Krause M. PRONTOX - proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial. Trials. 2016 Nov 15;17(1):543. doi: 10.1186/s13063-016-1679-4.