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

• ClinicalTrials.gov Identifier: NCT01973179
• Recruitment Status: Recruiting
• First Posted: October 31, 2013
• Last Update Posted: February 18, 2019
• Sponsor: Technische Universität Dresden
• Information provided by (Responsible Party): Mechthild Krause, Technische Universität Dresden

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Head-and-neck Carcinoma	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 Design

• Study Type: Observational
• Estimated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study to Re-irradiation for Recurrent Head and Neck Cancer
• Study Start Date: July 2015
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2023

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: STR-ReKo-2013
• First Posted: October 31, 2013
• Last Update Posted: February 18, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms