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Photon Versus Particle Therapy for Recurrent Lung Cancer; a Planning Study Based on a Reference Dataset of Patients.

2 settembre 2019 aggiornato da: Maastricht Radiation Oncology

In Silico Clinical Trial on Re-irradiation Lung Cancer, Comparing Photon, Proton and 12C-ion Therapy: A Multicentric ROCOCO Planning Study Based on a Reference Dataset of Patients.

Patients with lung cancer may develop a second primary tumor or recurrent disease after previous radiotherapy. Surgical salvage therapy is the mainstay of therapeutic options. However, in case of irresectable disease, re-irradiation should be considered. Also in the postoperative setting, re-irradiation is considered after surgical salvage in case of features in the pathology specimen indicating a high risk for subsequent recurrence. However after re-irradiation, there is a high risk of 43% grade 3 (late) toxicity at 5 years (including possible fatal complications) and a relatively low chance of locoregional control of 50% at 5 years. One out of three patients survives re-irradiation without recurrence and severe complications. Improvements in both the risk of radiation-induced complications and the oncological outcome are thus warranted.

Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the potential to inflict maximum damage on tumors with minimum collateral damage to neighboring healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that of conventional radiotherapy (RT) with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the situations in which PT outperforms conventional photon treatment is needed. Publications on this topic are rare. The only recent publication has analyzed the results of 37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy [Kruser in press].

We propose an in silico trial to investigate to what extend proton and 12C-ion therapy decrease the amount of irradiated normal tissue in lung cancer patients treated with radiotherapy after an initial radiotherapy treatment.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

For this in silico planning study all treatment plans will be performed in centers that are already operating and have experience in treatment planning. Photon treatment plans will be carried out in Maastricht, proton treatment plans at the University of Pennsylvania and the C-ion treatment plans at the University of Wisconsin.

A dataset with state-of-the-art image data is available. 25 patients will be included according to a-priori defined selection criteria. Each patient will function as his or her own control. For this reason, the number of patients per tumor group can be limited to 25 patients per tumor group (power = 80%, alpha = 5%).

The datasets will be stored on a secure website hosted by MAASTRO. High quality CT-images will be used for radiotherapy treatment planning. If available, secondary image information such as FDG-PET and MRI will be used for GTV delineation. All relevant OARs will be delineated in both the primary and secondary studyset. GTV/CTV will be used accordingly to the actual treatment. New DVH's will be calculated for the added OAR. Dose restrictions for the re-irradiation plan will be defined for each individual patient based on the DVH dose in the primary photon treatment plan.

Photons will be planned with direct Aperture Optimized Intensity Modulated Radiotherapy (IMRT). Protons will be planned using active beam delivery with Intensity Modulated proton therapy (IMPT)and carbon-ions with a pencil beam delivery treatment planning technique with gantry. Each participating center will use its own treatment planning system according to standard practice at that center. The GTV to PTV margin will be determined by the individual institutes according to the treatment technique and treatment modality. The same tumor dose, overall treatment time (OTT) and an equal number of fractions will be used for all treatment modalities.

Photon, proton and C-ion treatments will be compared based on dosimetric parameters on normal tissues. In addition, the NTCP for a fixed tumor dose or the same expected TCP will be determined. Cobalt Gy equivalent doses will be used when reporting the proton and carbon-ion dose. In the case of protons, a constant RBE value of 1.1 will be used for both the tumor and the normal tissues. The RBE of carbon-ions will be calculated based on the models used by the participating centers.

Dose in the following structures will be taken into account:

  • Lungs
  • Spinal court
  • Heart
  • Oesophagus

Tipo di studio

Osservativo

Iscrizione (Effettivo)

25

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
      • Maastricht, Olanda, 6229 ET
        • Maastricht radiation oncology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

25 patients with SCLC

Descrizione

Inclusion Criteria:

  • Re-irradiation patients for relapsed or second cancers in the left or the right lung
  • Received respitory gated CT (4DCT) and PET (4DPET) scans.
  • The primary treatment was radiotherapy with a curative intent
  • The organs at risk of the primary tumor treatment are the same organs at risk at the secondary treatment
  • 18 years or older

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
25 NSCLC patients
25 NSCLC patients who received curative radiotherapy. Re-irradiation can either be indicated for primary or secondary cancers in the lung. All patients referred for primary radiotherapy or chemoradiation after curative radiation therapy more or equal to one year ago with overlapping CTV will be included. The organs at risk of the primary tumor are the same organs at risk at the secondary treatment.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The amount of irradiated normal tissue: lung
Lasso di tempo: Up to ten months (planning time)
- lung: V30, V20, V13, V5, mean lung dose
Up to ten months (planning time)
The amount of irradiated normal tissue: Spinal cord
Lasso di tempo: Up to ten months
Spinal cord: Dmax
Up to ten months
The amount of irradiated normal tissue: esophagus
Lasso di tempo: Up to ten months
Esophagus: Dmax, mean dose (MD), V55, V35
Up to ten months
The amount of irradiated normal tissue: Heart
Lasso di tempo: Up to ten months
Heart: Total dose (TD), V65, V45, V40, V30, V20, V10, MD
Up to ten months
The amount of irradiated normal tissue: Integral dose
Lasso di tempo: Up to ten months
Integral dose
Up to ten months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Risk of side effects in the irradiated normal tissue
Lasso di tempo: Up to ten months
Up to ten months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Possibilities of hypofractionation
Lasso di tempo: Up to ten months
The possibilities of hypofractionation will be explored, as the number of fractions has a strong influence on the treatment dose.
Up to ten months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Maastricht Radiation Oncology

Collaboratori

University of Pennsylvania
University of Wisconsin, Madison

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2013

Completamento primario (Effettivo)

1 settembre 2019

Completamento dello studio (Effettivo)

1 settembre 2019

Date di iscrizione allo studio

Primo inviato

19 dicembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

6 gennaio 2014

Primo Inserito (Stima)

7 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 settembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ROCOCO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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