Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189967
• Other study ID #: STR-PORTAF-2014
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• conventional 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.
• accelerated fraction
In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology	Dresden
Germany	Universitätsklinikum Freiburg, Department of Radiation Therapy and Radiation Oncology	Freiburg
Germany	Praxis für Strahlentherapie Hamburg-Harburg	Hamburg
Germany	Universitätsklinikum des Saarlandes, Department of Radiotherapy and Radiation Oncology	Homburg
Germany	Klinikum der Universität München,Department of Radiation Therapy and Radiation Oncology	München
Germany	Klinikum rechts der Isar, Technische Universität München, Department of Radiation Therapy and Radiation Oncology	München
Germany	Marienhospital Stuttgart, Department of Radiotherapy and Palliative Medicine	Stuttgart
Germany	Universitätsklinikum Tübingen, Department of Radiation Therapy and Radiation Oncology	Tübingen
Poland	SPZOZ MSW; Warmia & Mazury Oncology Center; Warmia & Mazury Medical University	Olsztyn

Sponsors (4)

Lead Sponsor	Collaborator
Technische Universität Dresden	German Consortium for Translational Cancer Research, National Center for Radiation Research in Oncology Dresden/Heidelberg, Radiation Oncology Working Group of the German Cancer Society

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of local tumor control	Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).	36 months after therapy
Secondary	overall survival	Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.	36 months after therapy
Secondary	local recurrence-free survival	Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).	36 months after therapy
Secondary	acute toxicity	The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.	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.
Secondary	quality of life	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.	36 months after therapy
Secondary	distant metastases-free survival	Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.	36 months after therapy
Secondary	late toxicity	The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.	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.