PORTAF - postoperative radiotherapy of non-small cell lung cancer: accelerated versus conventional fractionation - study protocol for a randomized controlled trial
Research output: Contribution to journal › Research article › Contributed › peer-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 language | English |
---|---|
Article number | 608 |
Number of pages | 6 |
Journal | Trials |
Volume | 18 |
Publication status | Published - 20 Dec 2017 |
Peer-reviewed | Yes |
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