Non-Small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer, radiotherapy, accelerated fractionation, conventional fractionation, postoperative
Brief summary
In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).
Detailed description
This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.
Interventions
RADIATIONconventional fractionation
In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.
RADIATIONaccelerated fraction
In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.
Sponsors
German Consortium for Translational Cancer Research
National Center for Radiation Research in Oncology Dresden/Heidelberg
Radiation Oncology Working Group of the German Cancer Society
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed non-small cell lung cancer * previous tumor resection with curative intention * postoperative indication for irradiation (\> pN1 and/ or R1) * R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the restaging-imaging * exclusion of distant metastases (M0) * age \> 18 years * good general condition (ECOG performance status 0 or 1) * written informed consent * appropriate compliance to ensure close follow-up * women of childbearing age: adequate contraception
Exclusion criteria
* histologically confirmed small cell lung cancer * distant metastases * no written informed consent or lack of cooperation relating to therapy or follow-up * previous (\< 5 years) or concomitant other malignant disease (exception: malignant disease, which is very likely healed and not influenced therapy or follow up of the non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin cancers) * for proton therapy: heart pacemaker * previous radiotherapy of the thorax or lower neck region * pregnancy or lactation * participation in another intervention study or not completed follow-up of a intervention study. Exceptions are psychological studies, supportive or observation studies, the previous therapy of non-small cell lung cancer is in accordance with the guideline and the participation in radiotherapy studies is not excluded in the trial protocol of the previous study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of local tumor control | 36 months after therapy | Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence-free survival | 36 months after therapy | Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy). |
| acute toxicity | Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months. | The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0. |
| overall survival | 36 months after therapy | Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up. |
| distant metastases-free survival | 36 months after therapy | Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray. |
| late toxicity | Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months. | The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit. |
| quality of life | 36 months after therapy | The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit. |
Countries
Germany, Poland
Outcome results
None listed