Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer
Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial
2 other identifiers
interventional
76
1 country
5
Brief Summary
Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 head-and-neck-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 6, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedDecember 9, 2015
December 1, 2015
5 years
June 6, 2011
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin.
4 years
Secondary Outcomes (3)
To assess actuarial LRC, DFS, and OS rates.
4 years
To evaluate patients' quality of life (QOL).
4 years
To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.
4 years
Interventions
Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.
Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.
Eligibility Criteria
You may qualify if:
- Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
- No surgical resection of primary site or neck dissection (excisional biopsy of lymph node is permitted)
- Human Papilloma Virus (HPV) testing of tumor performed; HPV p16 by immunohistochemistry
- Stage III or IVa disease (T1-2N1-3M0, T3-4N0-3M0) excluding T1-2N1 oral cavity and tonsil primaries and any N2C or bilateral N3 disease. Patients with T2N0 cancer of the base of tongue and hypopharynx are eligible
- ECOG performance status 0-1
- Age \>18 years
- No current pregnancy
- No other invasive malignancies within the last 2 years Patients with basal cell or squamous cell skin cancers or carcinoma in situ of any site are eligible.
- No prior radiotherapy to the head and neck region
- No prior cisplatin chemotherapy
- No symptomatic coronary disease or myocardial infarction within the last 6 months
- Laboratory evaluation: ANC \> 2,000/mm3, platelets \>100,000/mm3, creatinine \< 1.5 mg/dl, creatinine clearance \> 50 ml/min, bilirubin \< 1.5 mg/dl, AST or ALT \< 2X upper normal limit
- Study-specific consent signed prior to entry
You may not qualify if:
- Second primary malignancy that is clinically detectable
- Inability or unwillingness to comply with chemoRT
- Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck.
- Metastatic disease (M1)
- Pregnant or breast-feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coastal Carolina Radiation Oncologylead
- National Cancer Institute (NCI)collaborator
- New Hanover Regional Medical Centercollaborator
Study Sites (5)
Coleman Radiation Oncology Center
Morehead City, North Carolina, 28557, United States
CarolinaEast Cancer Care
New Bern, North Carolina, 28561, United States
South Atlantic Radiation Oncology
Supply, North Carolina, 28462, United States
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, 28401, United States
Zimmer Cancer Center
Wilmington, North Carolina, 28401, United States
Related Publications (1)
Maguire PD, Papagikos M, Hamann S, Neal C, Meyerson M, Hayes N, Ungaro P, Kotz K, Couch M, Pollock H, Tepper J. Phase II trial of hyperfractionated intensity-modulated radiation therapy and concurrent weekly cisplatin for Stage III and IVa head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2011 Mar 15;79(4):1081-8. doi: 10.1016/j.ijrobp.2009.12.046. Epub 2010 Apr 8.
PMID: 20378262RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick D. Maguire, M.D.
Coastal Carolina Radiation Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2011
First Posted
June 13, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2016
Last Updated
December 9, 2015
Record last verified: 2015-12