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

NCT ID: NCT01372111

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cisplatin

Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.

Intervention Type DRUG

Elective Nodal Irradiation (ENI)

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.

Intervention Type RADIATION

Other Intervention Names

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Cis-Diamminedichloroplatinum, DDP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

New Hanover Regional Medical Center

OTHER

Sponsor Role collaborator

Coastal Carolina Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick D. Maguire, M.D.

Role: PRINCIPAL_INVESTIGATOR

Coastal Carolina Radiation Oncology

Locations

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Coleman Radiation Oncology Center

Morehead City, North Carolina, United States

Site Status

CarolinaEast Cancer Care

New Bern, North Carolina, United States

Site Status

South Atlantic Radiation Oncology

Supply, North Carolina, United States

Site Status

Coastal Carolina Radiation Oncology

Wilmington, North Carolina, United States

Site Status

Zimmer Cancer Center

Wilmington, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20378262 (View on PubMed)

Other Identifiers

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U54CA142152-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCRO11

Identifier Type: -

Identifier Source: org_study_id