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A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Primary Non-operated Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx.

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Trial Information

A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.


Inclusion Criteria:



- Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx,
hypopharynx or larynx

- Primary unresectable tumor and/or patients that refused surgery

- Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer

- Multidisciplinary decision of curative radiotherapy or radiochemotherapy

- Karnofsky performance status >= 70 %

- Age >= 18 years old

- Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

- High risk Human Papilloma Virus (HPV)

- 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 for at least 5 years.

- Distant metastases

- Pregnant or lactating women

- Creatinine clearance (Cockcroft-Gault) =< 60 mL/min

- 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:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.

Outcome Description:

18F-FDG-PET/CT scans will be performed.

Outcome Time Frame:

at 1 year

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Ethics Committee

Study ID:

2010/567

NCT ID:

NCT01341535

Start Date:

September 2011

Completion Date:

April 2015

Related Keywords:

  • Primary Non-operated Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx.
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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