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

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

dose de escalation

standard dose

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University Hospitals UZLeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control arm

Experimental de escalated arm

Arm Description

NID2Gy = 50 Gy Swallowing apparatus: standard dose

NID2Gy = 40 Gy Swallowing apparatus: Dmax ≤ 60 Gy at 1 cm Dmax ≤ 50 Gy at 1.5 cm from the GTV or PSTB edge

Outcomes

Primary Outcome Measures

overall rate of late dysphagia and neck fibrosis

Secondary Outcome Measures

locoregional control

Quality of life

Acute dysphagia

Full Information

NCT ID

NCT01812486

First Posted

March 11, 2013

Last Updated

March 15, 2013

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT01812486

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control arm

Arm Type

Active Comparator

Arm Description

NID2Gy = 50 Gy Swallowing apparatus: standard dose

Arm Title

Experimental de escalated arm

Arm Type

Experimental

Arm 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

Intervention Type

Radiation

Intervention Name(s)

dose de escalation

Other Intervention Name(s)

IMRT

Intervention Type

Radiation

Intervention Name(s)

standard dose

Primary Outcome Measure Information:

Title

overall rate of late dysphagia and neck fibrosis

Time Frame

5 years

Secondary Outcome Measure Information:

Title

locoregional control

Time Frame

5 years

Title

Quality of life

Time Frame

5 years

Title

Acute dysphagia

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

University Hospitals UZLeuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

32044165

Citation

Deschuymer S, Nevens D, Duprez F, Daisne JF, Dok R, Laenen A, Voordeckers M, De Neve W, Nuyts S. Randomized clinical trial on reduction of radiotherapy dose to the elective neck in head and neck squamous cell carcinoma; update of the long-term tumor outcome. Radiother Oncol. 2020 Feb;143:24-29. doi: 10.1016/j.radonc.2020.01.005. Epub 2020 Feb 7.

Results Reference

derived

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

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