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A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

Primary Purpose

Re-irradiation in Recurrent and Second Primary Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

[18F]FDG-PET-voxel intensity-based IMRT

About this trial

This is an interventional treatment trial for Re-irradiation in Recurrent and Second Primary Head and Neck Cancer

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
Primary unresectable tumor and/or patients refused surgery.
No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
Karnofsky performance status ≥70%.
Age ≥ 18 years old.
Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
Brachytherapy as treatment for second primary / recurrence.
Distant metastases.
Other second primary tumors that are not under control.
Pregnant or lactating women.
Elevated blood creatinine level.
Allergy to the CT-contrast agents.
Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Sites / Locations

Antwerp University Hospital
University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reirradiation of recurrent and 2nd primary head/neck cancer.

Arm Description

Outcomes

Primary Outcome Measures

To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).

To test feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy) in treatment of recurrent and second primary head and neck cancer in the previously irradiated territory.

Secondary Outcome Measures

Estimation time to progression.

Evaluation tumor response.

Number of Participants with Adverse Events.

Evaluation acute toxicity.

Full Information

NCT ID

NCT01427010

First Posted

August 29, 2011

Last Updated

April 17, 2018

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT01427010

Brief Title

A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

Official Title

A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (Actual)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory. This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary head and neck cancer.

6. Conditions and Keywords

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

Re-irradiation in Recurrent and Second Primary Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reirradiation of recurrent and 2nd primary head/neck cancer.

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

[18F]FDG-PET-voxel intensity-based IMRT

Intervention Description

Non-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment.

Primary Outcome Measure Information:

Title

Description

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Estimation time to progression.

Time Frame

At 6, 9 and 12 months

Title

Evaluation tumor response.

Time Frame

After 3 months.

Title

Number of Participants with Adverse Events.

Description

Evaluation acute toxicity.

Time Frame

Up to 3 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory. Primary unresectable tumor and/or patients refused surgery. No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer. Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer. Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab) Karnofsky performance status ≥70%. Age ≥ 18 years old. Informed consent obtained, signed and dated before specific protocol procedures. Exclusion Criteria: Previous radiotherapy for cT1-2 cN0 M0 glottic cancer. Brachytherapy as treatment for second primary / recurrence. Distant metastases. Other second primary tumors that are not under control. Pregnant or lactating women. Elevated blood creatinine level. Allergy to the CT-contrast agents. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilfried De Neve, Ph.D., M.D.

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antwerp University Hospital

City

Antwerp

Country

Belgium

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Related Info

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A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

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