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

Phase 3

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: standard dose; Radiation: dose de escalation

• Registration Number: NCT01812486
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

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

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2013-01
• Status Verified: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-15
• Last Update Submitted: 2013-03-15
• Study First Posted: 2013-03-18
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
overall rate of late dysphagia and neck fibrosis	5 years

Secondary Outcome Measures

Name	Time	Method
locoregional control	5 years
Quality of life	5 years
Acute dysphagia	2 years

Trial Locations

Locations (1)

University Hospitals UZLeuven; 🇧🇪 Leuven, Belgium