ROCOCO - Adaptive IMRT Versus IMPT in Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

— ROCOCO  

Official title:

In Silico Clinical Trial on Adaptive Radiotherapy in Oropharynx Cancer, Comparing Photon & Proton Therapy: A Multicentric ROCOCO Planning Study Based on a Reference Dataset.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02908386
• Other study ID #: 2016 ROCOCO HN
• Status: Withdrawn
• Phase: N/A
• First received: April 13, 2016
• Last updated: September 16, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2016
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Given the lack of evidence for the benefit of particle therapy in relevant cases, he investigators proposed an in silico trial to investigate the dosimetric effect of contour changes for OAR as well as tumor during chemoradiation in H&N patients. Photon and proton-therapy will be compared based on dosimetric data on 7 time points during treatment combined with plan robustness. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy.

A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and during RT (T1-T7)

Description:

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. ROCOCO (Radiation Oncology COllaborative Comparison) is commenced at MAASTRO in May 2007 to evaluate PT's cost-effectiveness .

It is well known that during radiation treatment of head and neck cancer (HN), shrinkage and displacement of tumour and organs at risk (OARs, e.g. parotid glands), as well as weight loss may cause significant radiation dose changes to target volumes and organs at risk , , . These phenomena may cause the necessity to re-plan the treatment at a certain moment in time. In the last years many different treatment planning studies have been performed showing that the optimum moment for re-planning varies: after 20 Gy, 35 or 46 Gy. But what the actual effect of the deformation is on dose in actually treated patients has not been reported.

The investigators propose an in silico trial to investigate the relevance of contour changes for OAR as well as tumor during chemo radiation in H&N patients which will eventually lead to replanning. In that way the investigators will be able to assess and compare the optimal timing for replanning for photon and proton therapy.

The investigators compare different treatments focusing on the effect of deformation on PTV coverage and normal tissue radiation exposure. A fixed tumor dose, using the same delineation of gross target volume (GTV), clinical target volume (CTV) is used. The planning target volume (PTV) will be determined by each treatment modality.

For the initial plan the best possible dose distribution will be determined using the planning-CT (reference scan). For every time point (CT-scan) the reference treatment plan will be projected on the actual CT scan and the dose will be recalculated without changing the treatment parameters. This will be done using both photons and protons. All treatment uncertainties including robustness will be taken into account. Dose differences in the target volume (CTV-GTV and PTV) and the OAR, as a result of tumor shrinkage during treatment will be evaluated for each time point and each treatment modality.

The objective of this study is to assess plan robustness and the optimal timing for replanning for photon and proton therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• patients with head and neck carcinoma who have been treated with radical intent 10 patients, all with a reference CT scan and CT scans at 7 time points during treatment.

Exclusion Criteria:

• patients with no head and neck cancer

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barker JL Jr, Garden AS, Ang KK, O'Daniel JC, Wang H, Court LE, Morrison WH, Rosenthal DI, Chao KS, Tucker SL, Mohan R, Dong L. Quantification of volumetric and geometric changes occurring during fractionated radiotherapy for head-and-neck cancer using an — View Citation

Geets X, Tomsej M, Lee JA, Duprez T, Coche E, Cosnard G, Lonneux M, Grégoire V. Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helica — View Citation

Ricchetti F, Wu B, McNutt T, Wong J, Forastiere A, Marur S, Starmer H, Sanguineti G. Volumetric change of selected organs at risk during IMRT for oropharyngeal cancer. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):161-8. doi: 10.1016/j.ijrobp.2010.01.071 — View Citation

Roelofs E, Engelsman M, Rasch C, Persoon L, Qamhiyeh S, de Ruysscher D, Verhaegen F, Pijls-Johannesma M, Lambin P; ROCOCO Consortium. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-smal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plan uncertainties and robustness	Investigate plan uncertainties and robustness for photon and proton therapy in adaptive H&N tumors	up to 26 weeks	No
Primary	Dose distribution	Dose values of seven time frames (T1-T7) are compared to the reference dose values on the planning CT for both photon and proton treatment plans.	up to 26 weeks	No
Secondary	Optimal timing for replanning	Determine the optimal timing for replanning for each modality when taking all the treatment uncertainties in account.	up to 26 weeks	No