Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01287390
First received: January 26, 2011
Last updated: February 1, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:
- adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
- reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Procedure: video fluoroscopy Procedure: extra imaging Other: scoring acute toxicity Other: scoring of late toxicity Other: scoring quality of life (QOL) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Reduction of acute and late treatment-induced dysphagia [ Time Frame: after 1 year ] [ Designated as safety issue: No ]Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
Secondary Outcome Measures:
- acute treatment-induced toxicity [ Time Frame: weekly during treatment ] [ Designated as safety issue: No ]
- late treatment-induced toxicity [ Time Frame: after 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
- tumor response: imaging [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
- tumor response: clinical examination [ Time Frame: after 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
- local, regional and distant control: imaging [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
- local, regional and distant control: clinical examination [ Time Frame: after 1,3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
- local, regional and distant control: biopsy [ Time Frame: from 3 months on ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard radiotherapy treatment
These patients receive the normal standard treatment.
|
Procedure: video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
Other: scoring acute toxicity
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
Other: scoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
Other: scoring quality of life (QOL)
Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).
|
|
Experimental: adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
|
Procedure: video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
Procedure: extra imaging
For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.
Other: scoring acute toxicity
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
Other: scoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
Other: scoring quality of life (QOL)
Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287390
Contacts
| Contact: Wilfried De Neve, MD, PhD | Wilfried.Deneve@ugent.be |
Locations
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Wilfried De Neve, PhD, MD Wilfried.Deneve@ugent.be | |
| Principal Investigator: Wilfried De Neve, PhD, MD | |
| University Hospital Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Sandra Nuyts, PhD, MD | |
| Principal Investigator: Sandra Nuyts, PhD, MD | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Wilfried De Neve, PhD, MD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01287390 History of Changes |
| Other Study ID Numbers: | 2011/012 |
| Study First Received: | January 26, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital, Ghent:
|
squamous cell carcinoma oral cavity oropharynx hypopharynx larynx |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Laryngeal Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Neoplasms by Site Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013