NCT01024829

Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using FDG-PET-CT Scan in Stage IB, II and III NSCLC

Dose Escalation by Boosting Radiation Dose Within the Primary Tumor on the Basis of a Pre-treatment FDG-PET-CT Scan in Stage IB, II and III NSCLC: a Randomized Phase II Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Increasing ("boosting") the radiation dose for patients with non-small cell lung carcinoma to the individual maximal dose which can safely be given. The question is if patients should receive this boost on the whole tumor on part of the tumor. Therefore patients are randomized for one of these two treatment options. All patients will receive 24 radiations. Dose increasement will be enabled by a so called integrated boost. Furthermore: \- PET imaging of hypoxia using \[18F\]HX4, single injection and then PET CT scanning two and four hours post injection.

Detailed description

A randomized phase II study will be conducted in patients with inoperable stage IB, II or III non-small cell lung cancer (NSCLC). The patients will be randomized to receive the standard 66 Gy given in 24 fractions of 2.75 Gy with an integrated boost to the primary tumor as a whole (Arm A) or with an integrated boost to the 50% SUVmax area of the primary tumor (of the pre-treatment FDG-PET scan) (Arm B). Both treatment arms may be combined with chemotherapy (concurrent or sequential). Patients fulfilling the eligibility criteria will be registered in the study, and an initial radiotherapy treatment planning will be performed. When an integrated boost to the primary tumor as a whole up to 72 Gy is not possible because of dose constraints, the patient will receive 66 Gy or lower according to the normal tissue tolerance (see below). They will not be randomized, but will be followed in the trial. As such, it will be clear which proportion of patients can receive an integrated boost and what the outcome is when dose-escalation is not possible. Stage IB-II patients receive radiotherapy alone, and stage III patients combined chemotherapy and radiation. The patients may have received induction chemotherapy up to two cycles before registration in this trial. The statistical calculations have been performed to deal with this patient heterogeneity. The primary objective of this study is to determine the local progression-free survival (LPFS)at 1 year. Secondary objectives will be * Toxicity as a function of radiotherapy dose and volume of the tissue irradiated. * Overall survival. * Quality of life Furthermore: * PET imaging of hypoxia using \[18F\]HX4, single injection and then PET CT scanning two and four hours post injection. * Dynamic Contrast-Enhanced CT imaging

Conditions

• NSCLC

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Radiotherapy

Timeline

• Start date: 2010-05-01
• Primary completion: 2020-12-01
• Completion: 2022-03-01
• First posted: 2009-12-03
• Last updated: 2022-01-21

Locations

7 sites across 5 countries: Belgium, Denmark, Netherlands, Sweden, United Kingdom