PORTAF - postoperative radiotherapy of non-small cell lung cancer: accelerated versus conventional fractionation - study protocol for a randomized controlled trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

Abstract

Background: In early-stage non-small cell lung cancer (NSCLC) without affected lymph nodes detected at staging, surgical resection is still the mainstay of treatment. However, in patients with metastatic mediastinal lymph nodes (pN2) or non-radically resected primary tumors (R1/R2), postoperative radiotherapy (possibly combined with chemotherapy) is indicated. So far, investigations about time factors affecting postoperative radiotherapy have only examined the waiting time defined as interval between surgery and start of radiotherapy, but not the overall treatment time (OTT) itself. Conversely, results from trials on primary radio(chemo) therapy in NSCLC show that longer OTT correlates with significantly worse local tumor control and overall survival rates. This time factor of primary radio(chemo) therapy is thought to mainly be based on repopulation of surviving tumor cells between irradiation fractions. It remains to be elucidated if such an effect also occurs when patients with NSCLC are treated with postoperative radiotherapy after surgery (and chemotherapy). Our own retrospective data suggest an advantage of shorter OTT also for postoperative radiotherapy in this patient group.Methods/design: This is a multicenter, prospective randomized trial investigating whether an accelerated course of postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy fractions) improves locoregional tumor control in NSCLC patients in comparison to conventional fractionation (5 fractions per week, 2 Gy fractions). Target volumes and total radiation doses will be stratified in both treatment arms based on individual risk factors.Discussion: For the primary endpoint of the study we postulate an increase in local tumor control from 70% to 85% 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 and quality of life for both treatment methods.

Details

Original languageEnglish
Article number608
Number of pages6
JournalTrials
Volume18
Publication statusPublished - 20 Dec 2017
Peer-reviewedYes

External IDs

Scopus 85038612981
WOS 000418652600003
PubMed 29262836
researchoutputwizard legacy.publication#79797
ORCID /0000-0002-7017-3738/work/150884930
ORCID /0000-0003-1776-9556/work/171065669

Keywords

Sustainable Development Goals

Keywords

  • Acceleration, Fractionation, Non-small-cell lung cancer (NSCLC), Overall treatment time, Phase II trial, Postoperative radiotherapy, Randomized clinical trial, Time factor