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

Technische Universität Dresden

Status: Enrolling

Conditions: Non-Small Cell Lung Cancer

Treatments: Radiation: Proton therapy; Radiation: Photon therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02731001

STR - PRONTOX - 2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Proton therapy

Experimental group

Description:

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

Treatment:

Radiation: Proton therapy

Photon therapy

Active Comparator group

Description:

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

Treatment:

Radiation: Photon therapy