NCT02421458

Brief Summary

RCT to compare two radiation schemes for palliative HeadNeck cancer

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

February 12, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

February 12, 2015

Last Update Submit

June 26, 2019

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

  • time to loco-regional progression

    caculated from date of response until the date of clinical deteriotion; accoriding to RECIST

    4 months

  • impact of both radiation schemes on QoL

    this will be measured by the EORTC questionnaires C30 and HN35; analysis will be performed by a random effects regression model

    2 years

Secondary Outcomes (5)

  • overall survival rates

    4 months

  • loco-regional control rates

    3 months

  • overall response rates

    2 year

  • compliance to the study treatments as assessed by completed treatment and follow-up visits

    4 months

  • the incidence of grade ≥ 2 acute and late toxicity

    2 years

Study Arms (2)

arm 1: 6 fractions of radiation

ACTIVE COMPARATOR

radiation in a 6 fractions scheme and a daily dose of 6 Gy

Radiation: 6 x 6 Gy

arm 2: 16 fractrions of radiation

ACTIVE COMPARATOR

radiation in a 16 fractions scheme and a daily dose of 3.125 Gy

Radiation: 16 x 3.125 Gy

Interventions

6 x 6 GyRADIATION

radiation in 6 fraction of 6 Gy, twice a week during 3 weeks

arm 1: 6 fractions of radiation
16 x 3.125 GyRADIATION

radiation in 16 fraction of 3.125 Gy, 4 times a week during 4 weeks

arm 2: 16 fractrions of radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed patients with primary non-metastatic carcinoma located in the oral cavity, oropharynx, larynx (except T1 glottic), hypopharynx, nasopharynx, paranasal sinuses and salivary gland and carcinoma of unknown primary in the head and neck region who are not suitable for radical treatment with surgery or (chemo) and, therefore, planned for treatment with radiotherapy in palliative setting.
  • Newly diagnosed patients with primary head and neck carcinoma with limited metastatic disease in a good general condition and few comorbidities (ACE-25 \<3) with life expectancy of at least 6 months are also eligible.
  • Age ≥ 18 years
  • WHO performance status 0-2
  • Signed written informed consent

You may not qualify if:

  • Patients with previously radiation treatment in the head and neck region, for any reason.
  • Patients with head and neck malignancies arising from skin, nose, thyroid gland or esophagus.
  • Patients with advanced stage sarcoma or lymphoma of the head and neck region.
  • Expected life expectancy of less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Medisch Spectrum Twente

Enschede, Overijssel, 7513 ER, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081 HZ, Netherlands

Location

Antoni van Leeuwenhoek

Amsterdam, 19066CX, Netherlands

Location

Radiotherapiegroep, lokatie Arnhem

Arnhem, 6815AD, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Maastro Clinic

Maastricht, NL-6229 ET, Netherlands

Location

Radboud umc

Nijmegen, 6225GA, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3008EA, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, 2260 AK, Netherlands

Location

Instituut Verbeeten

Tilburg, 5042 SB, Netherlands

Location

Related Publications (1)

  • Al-Mamgani A, Kessels R, Verhoef CG, Navran A, Hamming-Vrieze O, Kaanders JHAM, Steenbakkers RJHM, Tans L, Hoebers F, Ong F, van Werkhoven E, Langendijk JA. Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma. Radiother Oncol. 2020 Aug;149:181-188. doi: 10.1016/j.radonc.2020.05.020. Epub 2020 May 14.

    PMID: 32417345DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Abrahim Al-Mamgani, MD, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

April 20, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

June 28, 2019

Record last verified: 2019-06

Locations

NL(11)