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NCT Number: NCT02189967

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

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Dresden, Department of Radiation Therapy and Radiation Oncology, Dresden, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Fractionation

Radiation

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

Radiation

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

Primary outcomes

  1. assessment of local tumor control

    Time frame: 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 outcomes

  1. overall survival

    Time frame: 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.

  2. local recurrence-free survival

    Time frame: 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).

  3. acute toxicity

    Time frame: 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.

  4. quality of life

    Time frame: 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.

  5. distant metastases-free survival

    Time frame: 36 months after therapy

    Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.

  6. late toxicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • German Consortium for Translational Cancer Research
  • National Center for Radiation Research in Oncology Dresden/Heidelberg
  • Radiation Oncology Working Group of the German Cancer Society

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jul 15, 2014
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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