Clinical trial NCT02421458: Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer
Official title: Dutch Randomized Multicenter Trial COmparing twO PalliativE RAdiaTION Schemes for Incurable Head and Neck Cancer (COOPERATION)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: time to loco-regional progression
timeFrame: 4 months
measure: impact of both radiation schemes on QoL
timeFrame: 2 years
Secondary outcomes:
measure: overall survival rates
timeFrame: 4 months
measure: loco-regional control rates
timeFrame: 3 months
measure: overall response rates
timeFrame: 2 year
measure: compliance to the study treatments as assessed by completed treatment and follow-up visits
timeFrame: 4 months
measure: the incidence of grade ≥ 2 acute and late toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep, lokatie Arnhem
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastro Clinic
city: NIjmegen
country: Netherlands
facility: Radboud umc
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Tilburg
country: Netherlands
facility: Instituut Verbeeten
Study officials:
affiliation: The Netherlands Cancer Institute
name: Abrahim Al-Mamgani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.