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.
(see Contacts and Locations)
Verified June 2015 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: June 2, 2015
Last verified: June 2015
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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: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341535
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:
| 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: | June 2, 2015 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on September 23, 2016