Re-irradiation of Recurrent Head and Neck Cancer

Trial Title: Re-irradiation of Recurrent Head and Neck Cancer

NCT ID: NCT01973179

Condition: Head-and-neck Carcinoma

Conditions: Official terms:
Head and Neck Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Radiation
Intervention name: Radiation therapy
Description: Radiation therapy with protons
Arm group label: Radiation therapy

Summary: The goal of this observational study is to evaluate the toxicity and local tumor control of proton therapy for patients with head and neck cancer in a previously irradiated field. Standard of care for recurrent or secondary malignancies in a previously irradiated field is surgery. For inoperable patients or residual tumor after surgery, standard of care would be palliative chemotherapy. For a small subset of patients (good performance status, small radiation fields) re-irradiation can be performed. In this study the established concept of re-irradiation with photons will be transferred to proton radiotherapy. Proton therapy has the advantage of a steeper dose gradient to normal tissues, thus-theoretical advantages for lower toxicity.

Detailed description: OBJECTIVES: Primary: Evaluation of late toxicity of re-irradiation with protons, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field. Secondary: Evaluation of the efficacy (local control) and acute toxicity (after 24 Months) of re-irradiation with protons up to a dose of 60 Gy, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field. OUTLINE This is a single center observational study. In-house standard of care for patients (good performance status and with small tumors) with head and neck cancer in a previously (> 50 Gy) irradiated field is to irradiate the tumor with a hyperfractionated schedule and concurrent cisplatin up to a dose of 66 Gy. Dose limiting for this schedule is the incidence of acute and late toxicity induced by radiation. The purpose of the study is the evaluation of the safety of a treatment schedule based on the use of protons. Proton beam treatments will be delivered in 2 Gy fractions, 5 days per week, to a total dose of 60-66 Gy equivalent. Study visits are performed: During proton therapy once per week. Follow-up visits are scheduled every 3 months for the first 24 months after proton therapy. Primary endpoint is late toxicity 24 months after proton treatment.

Criteria for eligibility:

Study pop:
Patients with a recurrent or secondary head and neck carcinoma

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - tumor is located in a previously irradiated area with at least 50 Gy or there is an overlap of radiation fields with resulting total doses greater than 90 Gy to expect - tumor size and localization allow high dose re-irradiation (individual decision) - exclusion of distant metastases - Time interval between pre-irradiation and re- irradiation at least 1 year for local recurrence; at least 6 months for secondary tumor disease - age ≥ 18 years - previous radiotherapy treatment plans available - pre-treatment imaging (pre re-irradiation) available - good general condition (ECOG 0-1) - dental treatment performed, if necessary - in case of surgery before re-irradiation: resection status is R-1 or R-2 - clinical suspicion of residual tumor by very scarce surgical margins (<1 mm) - pathological secured extracapsular extension (ECE) - indications by an interdisciplinary tumor board - patient able to understand the intention and procedures of the trial, written informed consent Exclusion Criteria: - no description of the R- status after resection of the tumour - pregnancy - no written informed consent - distant metastases - interval between first and second irradiation < 6 months at secondary tumor or <1 year when local recurrence of previously irradiated tumor - simultaneous participation in another intervention study , if further treatment must be carried out

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden

Address:
City: Dresden
Zip: 01307
Country: Germany

Status: Recruiting

Contact:
Last name: Mechthild Krause, Prof.
Email: Mechthild.Krause@uniklinikum-dresden.de

Investigator:
Last name: Mechthild Krause, Prof.
Email: Principal Investigator

Start date: July 2015

Completion date: December 2026

Lead sponsor:
Agency: Technische Universität Dresden
Agency class: Other

Source: Technische Universität Dresden

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01973179