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Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Elective Nodal Irradiation (ENI)
Sponsored by
Coastal Carolina Radiation Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Stg III or IVa Squamous Cell Carcinoma., Advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Coleman Radiation Oncology Center
  • CarolinaEast Cancer Care
  • South Atlantic Radiation Oncology
  • Coastal Carolina Radiation Oncology
  • Zimmer Cancer Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess actuarial LRC, DFS, and OS rates.
To evaluate patients' quality of life (QOL).
To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.

Full Information

First Posted
June 6, 2011
Last Updated
December 8, 2015
Sponsor
Coastal Carolina Radiation Oncology
Collaborators
National Cancer Institute (NCI), New Hanover Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01372111
Brief Title
Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer
Official Title
Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coastal Carolina Radiation Oncology
Collaborators
National Cancer Institute (NCI), New Hanover Regional Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Stg III or IVa Squamous Cell Carcinoma., Advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cis-Diamminedichloroplatinum, DDP
Intervention Description
Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.
Intervention Type
Radiation
Intervention Name(s)
Elective Nodal Irradiation (ENI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
To assess actuarial LRC, DFS, and OS rates.
Time Frame
4 years
Title
To evaluate patients' quality of life (QOL).
Time Frame
4 years
Title
To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick D. Maguire, M.D.
Organizational Affiliation
Coastal Carolina Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coleman Radiation Oncology Center
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
CarolinaEast Cancer Care
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28561
Country
United States
Facility Name
South Atlantic Radiation Oncology
City
Supply
State/Province
North Carolina
ZIP/Postal Code
28462
Country
United States
Facility Name
Coastal Carolina Radiation Oncology
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Zimmer Cancer Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20378262
Citation
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.
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Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

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