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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor., Recurrent and Second Primary Squamous Cell Carcinoma of the Oropharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor., Recurrent and Second Primary Squamous Cell Carcinoma of the Hypopharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor., Recurrent and Second Primary Squamous Cell Carcinoma of the Larynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Description:

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.

Outcome Time Frame:

2 year

Safety Issue:

Yes

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ghent University Hospital

Authority:

Belgium: Ethics Committee

Study ID:

2011/536

NCT ID:

NCT01427010

Start Date:

January 2012

Completion Date:

June 2013

Related Keywords:

  • Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
  • Recurrent and Second Primary Squamous Cell Carcinoma of the Oropharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
  • Recurrent and Second Primary Squamous Cell Carcinoma of the Hypopharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
  • Recurrent and Second Primary Squamous Cell Carcinoma of the Larynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms

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