Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01812486
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : March 18, 2013
Sponsor:
Collaborator:
University Hospital, Ghent
Information provided by (Responsible Party):
Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven

Brief Summary:
A randomized clinical trial was initiated to investigate whether a reduction of the dose to the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a reduction of acute and late side effects without compromising tumor control.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: dose de escalation Radiation: standard dose Phase 3

Detailed Description:
  1. Study hypothesis

    Dose de-escalation in the elective nodal sites and off-target regions of the swallowing apparatus delivered by IMRT does reduce overall rate of late dysphagia and neck fibrosis comparing to the standard dose to the elective nodal sites.

  2. Primary endpoint

    To estimate the difference in overall rate of late dysphagia and neck fibrosis 1 year after the end of radiotherapy in patients receiving dose de-escalation to the elective nodal sites and off-target regions of the swallowing apparatus applying IMRT.

  3. Secondary endpoints

Local, regional and distant control Recurrence and site of recurrence Overall, disease-free and disease-specific survival Acute toxicity Quality of life


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose De-escalation to the Elective Nodal Sites, the Swallowing Apparatus and Neck Soft Tissues for Head and Neck Cancer: Multi-centre, Randomized Phase III Trial Using Image-guided Intensity-modulated Radiotherapy (IG-IMRT)
Study Start Date : May 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control arm
NID2Gy = 50 Gy Swallowing apparatus: standard dose
Radiation: standard dose
Experimental: Experimental de escalated arm
NID2Gy = 40 Gy Swallowing apparatus: Dmax ≤ 60 Gy at 1 cm Dmax ≤ 50 Gy at 1.5 cm from the GTV or PSTB edge
Radiation: dose de escalation
Other Name: IMRT




Primary Outcome Measures :
  1. overall rate of late dysphagia and neck fibrosis [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. locoregional control [ Time Frame: 5 years ]
  2. Quality of life [ Time Frame: 5 years ]
  3. Acute dysphagia [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

oral cavity, oropharynx, hypopharynx and larynx SCC Histolocervical lymph node metastases of unknown primary cancer Primary unresectable tumor and/or patients refused surgery Stage T2-4; T3-4 N0 Tany N1-3 for laryngeal cancer Karnofsky performance status ≥70% Age ≥ 18 years old

Exclusion Criteria:

Treatment combined with brachytherapy Prior irradiation to the head and neck region History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years Distant metastases Pregnant or lactating women Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.


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): NCT01812486


Locations
Layout table for location information
Belgium
University Hospitals UZLeuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
University Hospital, Ghent

Layout table for additonal information
Responsible Party: Dr. Sandra Nuyts, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01812486     History of Changes
Other Study ID Numbers: S50809
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms