Re-irradiation of Recurrent Head and Neck Cancer (ReKo)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head-and-neck Carcinoma
• Intervention / Treatment: Radiation: Radiation therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a recurrent or secondary head and neck carcinoma

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiation therapy; Radiotherapy with protons in patients with head and neck carcinoma	Radiation: Radiation therapy; Radiation therapy with protons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late toxicity	measured from the first day of treatment	24 months after therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute toxicity	measured from the first day of treatment	3 months after treatment
local recurrence free survival	measured from the first day of treatment	24 months after therapy
overall survival	measured from the first day of treatment	24 months after therapy
quality of life	measured from the first day of treatment	24 months after therapy

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Study Chair: Mechthild Krause, Prof., Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimated): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: STR-ReKo-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No