Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

— COOPERATION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02421458
• Other study ID #: M15CRH
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2018

Study information

• Verified date: June 2019
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RCT to compare two radiation schemes for palliative HeadNeck cancer

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Radiation:
• 6 x 6 Gy
radiation in 6 fraction of 6 Gy, twice a week during 3 weeks
• 16 x 3.125 Gy
radiation in 16 fraction of 3.125 Gy, 4 times a week during 4 weeks

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Radiotherapiegroep, lokatie Arnhem	Arnhem
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid Holland
Netherlands	Maastro Clinic	Maastricht
Netherlands	Radboud umc	NIjmegen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Instituut Verbeeten	Tilburg

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to loco-regional progression	caculated from date of response until the date of clinical deteriotion; accoriding to RECIST	4 months
Primary	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	2 years
Secondary	overall survival rates	RECIST	4 months
Secondary	loco-regional control rates	caculated from date of response until the date of clinical deteriotion; according to RECIST	3 months
Secondary	overall response rates	caculated from date of response until the date of clinical deteriotion; accoriding to RECIST	2 year
Secondary	compliance to the study treatments as assessed by completed treatment and follow-up visits	number of treatment fractions and follow-up visits	4 months
Secondary	the incidence of grade = 2 acute and late toxicity	scoring of AE according tot CTC 4.0	2 years