Trial | NCT01372111  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cisplatin ...

  • Study Participants

    76
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.
Study Started
Mar 31
2011
Primary Completion
Mar 31
2016
Anticipated
Last Update
Dec 09
2015
Estimate

Drug Cisplatin

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

  • Other names: Cis-Diamminedichloroplatinum, DDP

Radiation 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.

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.
No Results Posted