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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control arm

NID2Gy = 50 Gy Swallowing apparatus: standard dose

Group Type ACTIVE_COMPARATOR

standard dose

Intervention Type RADIATION

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

Group Type EXPERIMENTAL

dose de escalation

Intervention Type RADIATION

Interventions

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dose de escalation

Intervention Type RADIATION

standard dose

Intervention Type RADIATION

Other Intervention Names

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IMRT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No