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

NCT ID: NCT02731001

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2025-12-31

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton therapy

Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.

Group Type: EXPERIMENTAL

Proton therapy

Intervention Type: RADIATION

Photon therapy

Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy.

Group Type: ACTIVE_COMPARATOR

Photon therapy

Intervention Type: RADIATION

Interventions

Proton therapy

Intervention Type: RADIATION

Photon therapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Research Center

OTHER

Sponsor Role: collaborator

National Center for Radiation Research in Oncology Dresden/Heidelberg

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Prof. Esther Troost

Prof. Esther Troost

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esther Troost, Prof.

Role: STUDY_CHAIR

Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf

Locations

Department of Radiotherapy and Radiation Oncology

Dresden, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Esther Troost, Prof.

Role: CONTACT

str.studien@uniklinikum-dresden.de

+49 351 458 2238

Facility Contacts

Esther Troost, Prof.

Role: primary

str.studien@uniklinikum-dresden.de

+49 351 458 2238

References

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.

Reference Type: DERIVED

PMID: 27846903 (View on PubMed)

Other Identifiers

STR - PRONTOX - 2014

Identifier Type: -

Identifier Source: org_study_id