NCT01973179

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2015Dec 2026

First Submitted

Initial submission to the registry

October 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 6, 2025

Status Verified

January 1, 2024

Enrollment Period

11.2 years

First QC Date

October 25, 2013

Last Update Submit

February 4, 2025

Conditions

Head-and-neck Carcinoma

Outcome Measures

Primary Outcomes (1)

  • late toxicity

    measured from the first day of treatment

    24 months after therapy

Secondary Outcomes (4)

  • acute toxicity

    3 months after treatment

  • local recurrence free survival

    24 months after therapy

  • overall survival

    24 months after therapy

  • quality of life

    24 months after therapy

Study Arms (1)

Radiation therapy

Radiotherapy with protons in patients with head and neck carcinoma

Radiation: Radiation therapy

Interventions

Radiation therapyRADIATION

Radiation therapy with protons

Radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a recurrent or secondary head and neck carcinoma

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

October 25, 2013

First Posted

October 31, 2013

Study Start

July 1, 2015

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 6, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)