A Study Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer
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:
NCT01341535
First received: April 11, 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
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-FDG-PET/CT scans to adaptive 18F-FDG-PET-voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-FDG-PET/CT scans for head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Non-operated Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx. |
Radiation: Adaptive dose-painting-by-numbers Radiation: standard intensity-modulated radiotherapy (IMRT) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]18F-FDG-PET/CT scans will be performed.
Secondary Outcome Measures:
- Regional (elective neck) and distant control. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]18F-FDG-PET/CT scans will be performed.
- Topography of local and/or regional relapse. [ Time Frame: during the first year post-treatment ] [ Designated as safety issue: No ]18F-FDG-PET/CT scans will be performedduring the first year post-treatment time point of local and/or regional relapse
- Tumor response [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]18F-FDG-PET/CT scans will be performed
- Acute toxicity [ Time Frame: up to 12 months of follow-up ] [ Designated as safety issue: Yes ]
- Overall disease-specific, disease-free survival. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- Late toxicity [ Time Frame: up to 12 months of follow-up ] [ Designated as safety issue: Yes ]
- Time point of local and/or regional relapse. [ Time Frame: during the first year post-treatment ] [ Designated as safety issue: No ]18F-FDG-PET/CT scans will be performed.
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: adaptive dose-painting-by-numbers
This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm. |
Radiation: Adaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers.
|
|
Active Comparator: standard intensity-modulated radiotherapy (IMRT)
This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm. |
Radiation: standard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer.
|
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341535
Contacts
| Contact: Wilfried De Neve, Ph.D., M.D. | Wilfried.Deneve@ugent.be |
Locations
| Belgium | |
| Department of Radiotherapy, University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Wilfried De Neve, Ph.D., M.D. Wilfried.Deneve@ugent.be | |
| Principal Investigator: Wilfried De Neve, Ph.D., M.D. | |
| Clinique & Materinité Sainte Elisabeth | Recruiting |
| Namen, Belgium | |
| Contact: Jean-François Daisne, MD | |
| Principal Investigator: Jean-François Daisne, M.D. | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Wilfried De Neve, Ph.D., M.D. | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01341535 History of Changes |
| Other Study ID Numbers: | 2010/567 |
| Study First Received: | April 11, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013