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Head and Neck NeoplasmsCOOPERATIONNCT02421458

Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer

A study testing 6 x 6 Gy and 16 x 3.125 Gy in people with Head and Neck Neoplasms, run by The Netherlands Cancer Institute at 11 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RCT to compare two radiation schemes for palliative HeadNeck cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
6 x 6 Gy and 16 x 3.125 Gy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
11 sitesNetherlands
Study dates
Nov 2015to Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • OR
  • 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.
  • No chemotherapy or surgery is allowed before inclusion.
  • Age ≥ 18 years
  • WHO performance status 0-2
  • Signed written informed consent

Who cannot join

  • Patients with previously radiation treatment in the head and neck region, for any reason.
  • Chemotherapy or surgery for head and neck tumor before inclusion and no other concomitant anti-cancer therapy is allowed during study treatment.
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Netherlands11 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HZ

  • Antoni van Leeuwenhoek

    Amsterdam, 19066CX

  • Radiotherapiegroep, lokatie Arnhem

    Arnhem, 6815AD

  • Medisch Spectrum Twente

    Enschede, Overijssel, 7513 ER

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

  • Maastro Clinic

    Maastricht, NL-6229 ET

  • Radboud umc

    Nijmegen, 6225GA

  • Erasmus Medisch Centrum

    Rotterdam, 3008EA

  • Haaglanden Medisch Centrum

    The Hague, 2260 AK

  • Instituut Verbeeten

    Tilburg, 5042 SB

Other trials in Netherlands

About this study

Official title: Dutch Randomized Multicenter Trial COmparing twO PalliativE RAdiaTION Schemes for Incurable Head and Neck Cancer (COOPERATION)

RCT to compare two radiation schemes for palliative HeadNeck cancer

Read the detailed description

A substantial proportion of patients with head and neck (HNC) are not suitable for curative treatment with surgery and/or (chemo)radiotherapy (CRT) because of very advanced stage, significant comorbidities, bad general condition, distant metastasis, or a combination of these factors. Although radiotherapy (RT) is a commonly used option to achieve durable disease control and to alleviate troublesome symptoms, the data about the optimal radiation scheme and the impact of these schedules on quality of life (QoL) of these vulnerable patients is extremely scarce.

Although different radiation schemes are used worldwide (in the Netherlands, at least 15 different radiation schedules are used), it is currently not possible to identify the best RT scheme, based only on retrospective studies because of the major differences between these studies with regard to patient's demographics, radiation schedules given, the radiation technique used etc. Furthermore, no any information is available on the impact of these schemes on treatment-related toxicity and QoL.

This illustrates the urgent need for a multicenter randomized controlled trial (RCT) to identify the most optimal schemes of RT for this group of patients. Therefore, the investigators intend to initiate a prospective RCT comparing the survival, loco-regional control, toxicity, and QoL of two commonly used schemes. This study will be the first of his kind for palliative patients with HNC and will compare a short-course (6 fractions) with a long-course of radiotherapy (16 fractions). Because most of patients with incurable HNC have a poor performance status and major comorbidity and prefer limited number of visits to the hospital, it is quite reasonable to investigate whether a short scheme of radiotherapy with limited number of visits to the clinic as good as a relatively long-course of radiotherapy in terms of outcome, toxicity and QoL. This delicate balance between outcomes, possible toxicity and patient's comfort would justify the initiation of such randomized trial. The results of this study will in the nearby future enable us to indicate the radiation scheme best suits which patient category

Being tested
6 x 6 Gy, 16 x 3.125 Gy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6 x 6 GyRadiation

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

  • 16 x 3.125 GyRadiation

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

Study groups in NCT02421458
Study groupRoleWhat they receive
arm 1: 6 fractions of radiationActive comparatorradiation in a 6 fractions scheme and a daily dose of 6 Gy
Receives: Radiation: 6 x 6 Gy
arm 2: 16 fractrions of radiationActive comparatorradiation in a 16 fractions scheme and a daily dose of 3.125 Gy
Receives: Radiation: 16 x 3.125 Gy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to loco-regional progression

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

    Measured: 4 months

  2. 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

    Measured: 2 years

Secondary outcomes (5)

  1. overall survival rates

    RECIST

    Measured: 4 months

  2. loco-regional control rates

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

    Measured: 3 months

  3. overall response rates

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

    Measured: 2 year

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

    number of treatment fractions and follow-up visits

    Measured: 4 months

  5. the incidence of grade ≥ 2 acute and late toxicity

    scoring of AE according tot CTC 4.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2018
  4. Study completionNov 2018

Why it stopped: recruiting rate was to low

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02421458
Sponsor's protocol ID
M15CRH
Acronym
COOPERATION
Status last verified
Jun 2019
First submitted
12 Feb 2015
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32417345

Questions about this trial

What is this clinical trial studying?

A study testing 6 x 6 Gy and 16 x 3.125 Gy in people with Head and Neck Neoplasms, run by The Netherlands Cancer Institute at 11 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: recruiting rate was to low). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to loco-regional progression (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02421458, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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