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Trial record 11 of 1358 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

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

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ClinicalTrials.gov Identifier: NCT02421458
Recruitment Status : Recruiting
First Posted : April 20, 2015
Last Update Posted : February 14, 2018
Sponsor:
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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2021

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 ]
    RECIST

  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
Criteria

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.

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

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


Contacts
Contact: Abrahim Al-Mamgani, MD, PhD + 31 20 512 9111 a.almamgani@nki.nl

Locations
Netherlands
Medisch Spectrum Twente Recruiting
Enschede, Overijssel, Netherlands, 7513 ER
Contact: F Ong, MD, PhD    +3153 487 2000    f.ong@mst.nl   
Leids Universitair Medisch Centrum Not yet recruiting
Leiden, Zuid Holland, Netherlands, 2333 ZA
Contact: Martin A de Jong, MD    +31 71 526 9111    M.A.de_Jong@lumc.nl   
Contact: Corine MH de Jong       C.M.H.de_Jong@lumc.nl   
Vrije Universiteit Medisch Centrum Not yet recruiting
Amsterdam, Netherlands, 1081 HZ
Contact: Derek Rietveld, MD, PhD    020 4444444    dhf.rietveld@vumc.nl   
Principal Investigator: Derek Rietveld, MD, PhD         
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands, 19066CX
Contact: Abrahim Al-Mamgani, MD,PhD    +31 20 512 9111    a.almamgani@nki.nl   
Contact: Hester Visser    +31 20 512 9111    he.visser@nki.nl   
Radiotherapiegroep, lokatie Arnhem Recruiting
Arnhem, Netherlands, 6815AD
Contact: Bas Kreike, MD    +31 26-3712412    b.kreike@arnhemrti.nl   
Haaglanden Medisch Centrum Not yet recruiting
Den Haag, Netherlands, 2260 AK
Contact: J Franssen, MD    (070) 330 20 00    j.franssen@haaglandenmc.nl   
Principal Investigator: J Franssen, MD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Hans Langendijk, MD PhD    +3150 361 6161    j.a.langendijk@umcg.nl   
Principal Investigator: Hans Langendijk, MD PhD         
Maastro Clinic Recruiting
Maastricht, Netherlands, NL-6229 ET
Contact: Frank Hoebers, MD    +31 88 4455521    frank.hoebers@maastro.nl   
Principal Investigator: Frank Hoebers, MD         
Radboud umc Recruiting
NIjmegen, Netherlands, 6225GA
Contact: Lia G. Verhoef, MD, PhD    +31 24 361 1111    Lia.Verhoef@radboudumc.nl   
Principal Investigator: Lia Verhoef, MD, PhD         
Erasmus Medisch Centrum Not yet recruiting
Rotterdam, Netherlands, 3008EA
Contact: Lisa Tans, MD, PhD       l.tans@erasmusmc.nl   
Principal Investigator: Lisa Tans, MD, PhD         
Instituut Verbeeten Recruiting
Tilburg, Netherlands, 5042 SB
Contact: R. L Poorter, MD    +31 13 594 7559    poorter.r@bvi.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02421458     History of Changes
Other Study ID Numbers: M15CRH
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms