## Protocol Section
### Identification Module
**NCT ID:** NCT01973179

**Acronym:** ReKo

**Brief Title:** Re-irradiation of Recurrent Head and Neck Cancer

**Official Title:** Observational Study to Re-irradiation for Recurrent Head and Neck Cancer

#### Organization Study ID Info
**ID:** STR-ReKo-2013
#### Organization
**Class:** OTHER
**Full Name:** Technische Universität Dresden
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-07

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2013-10-31
**Type:** ESTIMATED
**Study First Submit Date:** 2013-10-25
**Study First Submit QC Date:** 2013-10-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Technische Universität Dresden

#### Responsible Party

**Investigator Affiliation:** Technische Universität Dresden

**Investigator Full Name:** Mechthild Krause

**Investigator Title:** Prof. Dr. med.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Head-and-neck Carcinoma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Radiotherapy with protons in patients with head and neck carcinoma

**Intervention Names:**

- Radiation: Radiation therapy

**Label:** Radiation therapy

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Radiation therapy

**Description:** Radiation therapy with protons

**Name:** Radiation therapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** measured from the first day of treatment

**Measure:** late toxicity

**Time Frame:** 24 months after therapy

#### Secondary Outcomes

**Description:** measured from the first day of treatment

**Measure:** acute toxicity

**Time Frame:** 3 months after treatment

**Description:** measured from the first day of treatment

**Measure:** local recurrence free survival

**Time Frame:** 24 months after therapy

**Description:** measured from the first day of treatment

**Measure:** overall survival

**Time Frame:** 24 months after therapy

**Description:** measured from the first day of treatment

**Measure:** quality of life

**Time Frame:** 24 months after therapy

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Mechthild.Krause@uniklinikum-dresden.de

**Name:** Mechthild Krause, Prof.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dresden

**Contacts:**

***Contact 1:***

- **Email:** Mechthild.Krause@uniklinikum-dresden.de

- **Name:** Mechthild Krause, Prof.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mechthild Krause, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

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

**State:** Saxony

**Status:** RECRUITING

**Zip:** 01307

#### Overall Officials

**Official 1:**

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

**Name:** Mechthild Krause, Prof.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Head and Neck Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006258

- Term: Head and Neck Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
