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

U

Universitaire Ziekenhuizen KU Leuven

Status and phase

Completed
Phase 3

Conditions

Head and Neck Cancer

Treatments

Radiation: dose de escalation
Radiation: standard dose

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

control arm
Active Comparator group
Description:
NID2Gy = 50 Gy Swallowing apparatus: standard dose
Treatment:
Radiation: standard dose
Experimental de escalated arm
Experimental group
Description:
NID2Gy = 40 Gy Swallowing apparatus: Dmax ≤ 60 Gy at 1 cm Dmax ≤ 50 Gy at 1.5 cm from the GTV or PSTB edge
Treatment:
Radiation: dose de escalation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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