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Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.


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

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Trial Information

Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.


Inclusion Criteria:



- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx and larynx.

- Primary non-resected tumor and/or patients refused surgery

- Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3

- Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary
Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven

- Karnofsky performance status >= 70 %

- Age >= 18 years old

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

Exclusion Criteria:

- Treatment combined with brachytherapy

- Prior irradiation to the head and neck region

- Surgery of the primary tumor except lymph node dissection prior to radiotherapy

- induction chemotherapy

- 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

- Creatinine clearance (Cockroft-Gault) =< 60 milliliter/minute before treatment or
creatinine value > 1,3 milligram/deciliter

- Known allergy to the CT-contrast agents

- Pregnant or lactating women

- 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction of acute and late treatment-induced dysphagia

Outcome Description:

Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.

Outcome Time Frame:

after 1 year

Safety Issue:

No

Principal Investigator

Wilfried De Neve, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Ethics Committee

Study ID:

2011/012

NCT ID:

NCT01287390

Start Date:

October 2011

Completion Date:

December 2015

Related Keywords:

  • Primary Non-operated Squamous Cell Carcinoma of Oral Cavity
  • Primary Non-operated Squamous Cell Carcinoma of Oropharynx
  • Primary Non-operated Squamous Cell Carcinoma of Hypopharynx
  • Primary Non-operated Squamous Cell Carcinoma of Larynx
  • squamous cell carcinoma
  • oral cavity
  • oropharynx
  • hypopharynx
  • larynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms

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