ROCOCO - Adaptive IMRT Versus IMPT in Head and Neck Cancer (ROCOCO)

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

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)

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Neoplasms

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 10 consecutive patients treated with proton therapy at the University of Pennsylvania (USA). Other treatment modalities for the tumor sites, such as chemotherapy will not be taken into account. Included are H&N patients who have been treated with radical intent. Each patient will function as his or her own control.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plan uncertainties and robustness	Investigate plan uncertainties and robustness for photon and proton therapy in adaptive H&N tumors	up to 26 weeks

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Collaborators: University of Pennsylvania
• Investigators: Study Director: Philippe Lambin, Prof dr, Maastro Clinic, The Netherlands

Publications and helpful links

General Publications

• 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-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):165-76. doi: 10.1097/JTO.0b013e31823529fc.
• 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 integrated CT/linear accelerator system. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):960-70. doi: 10.1016/j.ijrobp.2003.12.024.
• 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. Epub 2010 Nov 19.
• Geets X, Tomsej M, Lee JA, Duprez T, Coche E, Cosnard G, Lonneux M, Gregoire V. Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helical tomotherapy. Radiother Oncol. 2007 Oct;85(1):105-15. doi: 10.1016/j.radonc.2007.05.010. Epub 2007 Jun 11.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Proton; Head and neck tumors; Photon; replanning timing
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2016 ROCOCO HN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES