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Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer (COOPERATION)

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ClinicalTrials.gov Identifier: NCT02421458
Recruitment Status : Terminated (recruiting rate was to low)
First Posted : April 20, 2015
Last Update Posted : June 28, 2019
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
RCT to compare two radiation schemes for palliative HeadNeck cancer

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Radiation: 6 x 6 Gy Radiation: 16 x 3.125 Gy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dutch Randomized Multicenter Trial COmparing twO PalliativE RAdiaTION Schemes for Incurable Head and Neck Cancer (COOPERATION)
Study Start Date : November 2015
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: arm 1: 6 fractions of radiation
radiation in a 6 fractions scheme and a daily dose of 6 Gy
Radiation: 6 x 6 Gy
radiation in 6 fraction of 6 Gy, twice a week during 3 weeks

Active Comparator: arm 2: 16 fractrions of radiation
radiation in a 16 fractions scheme and a daily dose of 3.125 Gy
Radiation: 16 x 3.125 Gy
radiation in 16 fraction of 3.125 Gy, 4 times a week during 4 weeks

Primary Outcome Measures :
  1. time to loco-regional progression [ Time Frame: 4 months ]
    caculated from date of response until the date of clinical deteriotion; accoriding to RECIST

  2. impact of both radiation schemes on QoL [ Time Frame: 2 years ]
    this will be measured by the EORTC questionnaires C30 and HN35; analysis will be performed by a random effects regression model

Secondary Outcome Measures :
  1. overall survival rates [ Time Frame: 4 months ]

  2. loco-regional control rates [ Time Frame: 3 months ]
    caculated from date of response until the date of clinical deteriotion; according to RECIST

  3. overall response rates [ Time Frame: 2 year ]
    caculated from date of response until the date of clinical deteriotion; accoriding to RECIST

  4. compliance to the study treatments as assessed by completed treatment and follow-up visits [ Time Frame: 4 months ]
    number of treatment fractions and follow-up visits

  5. the incidence of grade ≥ 2 acute and late toxicity [ Time Frame: 2 years ]
    scoring of AE according tot CTC 4.0

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421458

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Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7513 ER
Leids Universitair Medisch Centrum
Leiden, Zuid Holland, Netherlands, 2333 ZA
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081 HZ
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 19066CX
Radiotherapiegroep, lokatie Arnhem
Arnhem, Netherlands, 6815AD
Haaglanden Medisch Centrum
Den Haag, Netherlands, 2260 AK
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Maastro Clinic
Maastricht, Netherlands, NL-6229 ET
Radboud umc
NIjmegen, Netherlands, 6225GA
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3008EA
Instituut Verbeeten
Tilburg, Netherlands, 5042 SB
Sponsors and Collaborators
The Netherlands Cancer Institute
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Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02421458    
Other Study ID Numbers: M15CRH
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site