Trial record 1 of 1 for: NCT01973179

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

This study is currently recruiting participants.

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Contacts and Locations

Verified July 2017 by Mechthild Krause, Technische Universität Dresden

Sponsor:

Information provided by (Responsible Party):

Mechthild Krause, Technische Universität Dresden

ClinicalTrials.gov Identifier:

NCT01973179

First received: October 25, 2013

Last updated: July 25, 2017

Last verified: July 2017

History of Changes

Purpose

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.

Condition	Intervention
Head-and-neck Carcinoma	Radiation: Radiation therapy


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Observational Study to Re-irradiation for Recurrent Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Mechthild Krause, Technische Universität Dresden:

Primary Outcome Measures:

late toxicity [ Time Frame: 24 months after therapy ]
measured from the first day of treatment

Secondary Outcome Measures:

acute toxicity [ Time Frame: 3 months after treatment ]
measured from the first day of treatment
local recurrence free survival [ Time Frame: 24 months after therapy ]
measured from the first day of treatment
overall survival [ Time Frame: 24 months after therapy ]
measured from the first day of treatment
quality of life [ Time Frame: 24 months after therapy ]
measured from the first day of treatment


Estimated Enrollment:	50
Study Start Date:	July 2015
Estimated Study Completion Date:	August 2023
Estimated Primary Completion Date:	August 2022 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Radiation therapy Radiotherapy with protons in patients with head and neck carcinoma	Radiation: Radiation therapy Radiation therapy with protons

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with a recurrent or secondary head and neck carcinoma

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973179

Contacts


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

Locations


Germany
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden	Recruiting
Dresden, Saxony, Germany, 01307
Contact: Mechthild Krause, Prof. Mechthild.Krause@uniklinikum-dresden.de
Principal Investigator: Mechthild Krause, Prof.

Sponsors and Collaborators

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

More Information


Responsible Party:	Mechthild Krause, Prof. Dr. med., Technische Universität Dresden
ClinicalTrials.gov Identifier:	NCT01973179 History of Changes
Other Study ID Numbers:	STR-ReKo-2013
Study First Received:	October 25, 2013
Last Updated:	July 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms by Site Neoplasms

ClinicalTrials.gov processed this record on August 22, 2017

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