State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning Study

NCT02242916 | Completed DMC

• 1 other identifier: ROCOCO re-irradiation HN
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Given that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations in which proton therapy outperforms conventional photon treatment is needed. The investigators therefore aim to demonstrate through an in silico trial that proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. The same overall treatment time and an equal number of fractions will be used for both treatment modalities wherever possible. The most optimal technique for each individual patient, based on objective criteria related to limiting dose to normal tissue, will be prescribed by the institution concerned for each treatment option.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Keywords

reccurent Head and Neck tumors; re-irradiation; photon; proton; carbon-ion

Outcome Measures

Primary Outcomes (1)

• Radiation exposure for organs at risk in H&N cancer patients

  Radiation exposure for organs at risk in H\&N patients treated with radiotherapy for recurrent tumors after primary radiotherapy. Results are based on in silico planning study which compares photon, proton and Carbon-ion treatments. The same biological radiation dose, fractionation schedule and tumor dose inhomogeneity is used. A wide range of OAR is included in this study, to be able to document doses to organs that are further away from the target volume, and also to quantify low doses to organs.

  7 weeks

Secondary Outcomes (1)

• Normal tissue complication probability (NTCP) for a fixed tumor dose

  3 years

Other Outcomes (1)

• Risk of secondary cancer

  10 years

Study Arms (1)

Patients with recurrent HN tumors

Patients with recurrent Head and Neck tumors

Radiation: Photon therapy versus proton therapy; Radiation: Photon therapy versus C-ion therapy

Interventions

Photon therapy versus proton therapy RADIATION

Patients with recurrent HN tumors

Photon therapy versus C-ion therapy RADIATION

Patients with recurrent HN tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with recurrent head and neck tumors

You may qualify if:

• Primary treatment:
• ≥ 50 Gy with curative intent (with or without chemo)
• CTV includes primary tumor and at least level II-IV
• Severe dental scatter artifacts or metal implants of unknown density will be excluded
• IMRT plan available
• Secondary treatment after ≥ 1 year, dose 70 Gy
• a. Severe dental scatter artifacts or metal implants of unknown density will be excluded
• Overlap of at least one OAR in primary and secondary treatment

You may not qualify if:

• Patients referred for postoperative radiotherapy

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• University of Pennsylvania: collaborator
• Philipps University Marburg: collaborator
• University Medical Center Nijmegen: collaborator

Study Sites (1)

Maastro Clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Danielle Eekers, Dr.

  Maastro Clinic, Dr Tanslaan 12, Maastricht, The Netherlands

  PRINCIPAL INVESTIGATOR

• Philippe lambin, prof, Dr

  Maastro Clinic, Dr Tanslaan 12, Maastricht, The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

NL (1)