Re-irradiation of Recurrent Head and Neck Cancer

Head-and-neck Carcinoma Clinical Trial

— ReKo  

Official title:

Observational Study to Re-irradiation for Recurrent Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973179
• Other study ID #: STR-ReKo-2013
• Status: Recruiting
• Start date: July 2015
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Technische Universität Dresden
• Contact: Mechthild Krause, Prof.
• Email: Mechthild.Krause[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head-and-neck Carcinoma

Intervention

Radiation:
• Radiation therapy
Radiation therapy with protons

Locations

Country	Name	City	State
Germany	Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late toxicity	measured from the first day of treatment	24 months after therapy
Secondary	acute toxicity	measured from the first day of treatment	3 months after treatment
Secondary	local recurrence free survival	measured from the first day of treatment	24 months after therapy
Secondary	overall survival	measured from the first day of treatment	24 months after therapy
Secondary	quality of life	measured from the first day of treatment	24 months after therapy