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

Non-Small Cell Lung Cancer Clinical Trial

— PRONTOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731001
• Other study ID #: STR - PRONTOX - 2014
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2025

Study information

• Verified date: August 2021
• Source: Technische Universität Dresden
• Contact: Esther Troost, Prof.
• Phone: +49 351 458 2238
• Email: str.studien[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2025
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Radiation:
• Proton therapy

• Photon therapy

Locations

Country	Name	City	State
Germany	Department of Radiotherapy and Radiation Oncology	Dresden

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of acute and intermediate radiation induced side effects		no later than six months after end of treatment