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Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity (UPGRADE-RT)

Primary Purpose

Head and Neck Neoplasms, Carcinoma, Squamous Cell

Status

Active

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

standard dose prescription

FDG-PET guided gradient dose prescription

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring head and neck cancer, accelerated radiotherapy, dose reduction, dose de-escalation, elective lymph nodes, FDG-PET

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly diagnosed tumours classified as stage T2-4 N0-2 (TNM 7th edition 2009) located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible)
Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour
Decision for curative intent external beam radiotherapy with elective treatment of the neck made by a multidisciplinary head-and-neck oncology team. The patient must be expected to complete the treatment.
Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment
No distant metastasis (M0) (TNM 7th edition 2009)
WHO performance status 0-2
≥ 18 years of age
Written informed consent

Exclusion Criteria:

Concomitant chemotherapy or EGFR inhibitors for this tumour.
Primary tumour of the oral cavity or unknown primary tumour
Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumour reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or radiotherapy), except for endoscopic glottic laser micro surgery.
Current participation in any other oncologic interventional clinical study for this tumor.
Uncontrolled diabetes mellitus.
Known or suspected HIV infection.
History of previous malignancy within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, basal/squamous cell carcinoma of the skin, and other non-invasive malignancies (e.g. in situ carcinomas)..
Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.

Sites / Locations

VU University Medical Center Amsterdam
Radiotherapiegroep, Arnhem
MAASTRO clinic, Maastricht
Radboud University Nijmegen Medical Center
University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard dose prescription

FDG-PET guided gradient dose prescription

Arm Description

FDG-PET-scan in treatment mask for radiotherapy planning Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)

Outcomes

Primary Outcome Measures

Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)

Secondary Outcome Measures

Safety: recurrence in electively irradiated lymph nodes

A Kaplan-Meier estimate will be calculated

Full Information

NCT ID

NCT02442375

First Posted

April 21, 2015

Last Updated

March 29, 2023

Sponsor

Radboud University Medical Center

Collaborators

UMC Utrecht, Amsterdam UMC, location VUmc, Maastro Clinic, The Netherlands, Radiotherapiegroep

1. Study Identification

Unique Protocol Identification Number

NCT02442375

Brief Title

Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity

Acronym

UPGRADE-RT

Official Title

Uniform FDG-PET Guided GRAdient Dose prEscription to Reduce Late Radiation Toxicity (UPGRADE-RT): a Randomised Controlled Trial With Dose Reduction to the Elective Neck in Head and Neck Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 2016 (Actual)

Primary Completion Date

January 25, 2024 (Anticipated)

Study Completion Date

January 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

Collaborators

UMC Utrecht, Amsterdam UMC, location VUmc, Maastro Clinic, The Netherlands, Radiotherapiegroep

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life after treatment whilst the recurrence rate in electively irradiated lymph nodes should not be compromised. A summary of the study protocol can be found here: http://rdcu.be/qgMv

6. Conditions and Keywords

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

Head and Neck Neoplasms, Carcinoma, Squamous Cell

Keywords

head and neck cancer, accelerated radiotherapy, dose reduction, dose de-escalation, elective lymph nodes, FDG-PET

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard dose prescription

Arm Type

Active Comparator

Arm Description

FDG-PET-scan in treatment mask for radiotherapy planning Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)

Arm Title

FDG-PET guided gradient dose prescription

Arm Type

Experimental

Arm Description

FDG-PET-scan in treatment mask for radiotherapy planning Accelerated radiotherapy IMRT/VMAT with SIB (34 fraction in 5.5 weeks)

Intervention Type

Radiation

Intervention Name(s)

standard dose prescription

Intervention Description

standard elective dose no intermediate dose-level visual interpretation of FDG-PET-scan

Intervention Type

Radiation

Intervention Name(s)

FDG-PET guided gradient dose prescription

Intervention Description

de-escalation of elective dose intermediate dose-level standardized methods to evaluate FDG-PET-scan

Primary Outcome Measure Information:

Title

Toxicity: normalcy of diet (score of the performance status scale for head and neck cancer patients)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Safety: recurrence in electively irradiated lymph nodes

Description

A Kaplan-Meier estimate will be calculated

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

Acute toxicity (common toxicity criteria v2.0)

Time Frame

up to 3 months

Title

Late toxicity: swallowing function (water swallowing test)

Time Frame

3, 12 and 24 months

Title

Late toxicity: salivary gland function (stimulated flow rates)

Time Frame

3, 12 and 24 months

Title

Late toxicity: thyroid gland function (thyroid stimulating hormone blood test)

Time Frame

3, 12 and 24 months

Title

Quality of life (EORTC QLQ-C30 and QLQ-H&N35 questionnaires)

Time Frame

3, 6, 12 and 24 months

Title

Xerostomia related quality of life (GRIX questionnaire)

Time Frame

3, 6, 12 and 24 months

Title

Dysphagia related quality of life (SWAL-QOL questionnaire)

Time Frame

3, 6, 12 and 24 months

Title

Loco-regional control

Description

A Kaplan-Meier estimate will be calculated

Time Frame

24 months

Title

Overall survival

Description

A Kaplan-Meier estimate will be calculated

Time Frame

24 months

Title

Disease specific survival

Description

A Kaplan-Meier estimate will be calculated

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed tumours classified as stage T2-4 N0-2 (TNM 7th edition 2009) located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible) Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour Decision for curative intent external beam radiotherapy with elective treatment of the neck made by a multidisciplinary head-and-neck oncology team. The patient must be expected to complete the treatment. Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment No distant metastasis (M0) (TNM 7th edition 2009) WHO performance status 0-2 ≥ 18 years of age Written informed consent Exclusion Criteria: Concomitant chemotherapy or EGFR inhibitors for this tumour. Primary tumour of the oral cavity or unknown primary tumour Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumour reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or radiotherapy), except for endoscopic glottic laser micro surgery. Current participation in any other oncologic interventional clinical study for this tumor. Uncontrolled diabetes mellitus. Known or suspected HIV infection. History of previous malignancy within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, basal/squamous cell carcinoma of the skin, and other non-invasive malignancies (e.g. in situ carcinomas).. Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Dr. J.H.A.M. Kaanders

Organizational Affiliation

Radboud University Nijmegen Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

VU University Medical Center Amsterdam

City

Amsterdam

Country

Netherlands

Facility Name

Radiotherapiegroep, Arnhem

City

Arnhem

Country

Netherlands

Facility Name

MAASTRO clinic, Maastricht

City

Maastricht

Country

Netherlands

Facility Name

Radboud University Nijmegen Medical Center

City

Nijmegen

Country

Netherlands

Facility Name

University Medical Center Utrecht

City

Utrecht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28327089

Citation

van den Bosch S, Dijkema T, Kunze-Busch MC, Terhaard CH, Raaijmakers CP, Doornaert PA, Hoebers FJ, Vergeer MR, Kreike B, Wijers OB, Oyen WJ, Kaanders JH. Uniform FDG-PET guided GRAdient Dose prEscription to reduce late Radiation Toxicity (UPGRADE-RT): study protocol for a randomized clinical trial with dose reduction to the elective neck in head and neck squamous cell carcinoma. BMC Cancer. 2017 Mar 21;17(1):208. doi: 10.1186/s12885-017-3195-7.

Results Reference

background

Links:

URL

http://rdcu.be/qgMv

Description

Study protocol

Learn more about this trial

Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity

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