Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer (COOPERATION)
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| ClinicalTrials.gov Identifier: NCT02421458 |
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Recruitment Status :
Terminated
(recruiting rate was to low)
First Posted : April 20, 2015
Last Update Posted : June 28, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Neoplasms | Radiation: 6 x 6 Gy Radiation: 16 x 3.125 Gy | Not Applicable |
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) |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: arm 1: 6 fractions of radiation
radiation in a 6 fractions scheme and a daily dose of 6 Gy
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Radiation: 6 x 6 Gy
radiation in 6 fraction of 6 Gy, twice a week during 3 weeks |
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Active Comparator: arm 2: 16 fractrions of radiation
radiation in a 16 fractions scheme and a daily dose of 3.125 Gy
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Radiation: 16 x 3.125 Gy
radiation in 16 fraction of 3.125 Gy, 4 times a week during 4 weeks |
- time to loco-regional progression [ Time Frame: 4 months ]caculated from date of response until the date of clinical deteriotion; accoriding to RECIST
- 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
- overall survival rates [ Time Frame: 4 months ]RECIST
- loco-regional control rates [ Time Frame: 3 months ]caculated from date of response until the date of clinical deteriotion; according to RECIST
- overall response rates [ Time Frame: 2 year ]caculated from date of response until the date of clinical deteriotion; accoriding to RECIST
- 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
- 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.
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:
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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
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
| Netherlands | |
| 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 | |
| Principal Investigator: | Abrahim Al-Mamgani, MD, PhD | The Netherlands Cancer Institute |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Head and Neck Neoplasms Neoplasms by Site Neoplasms |