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Phase 3 N=743 Randomized Treatment

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00047008 ↗
Enrolled (actual)
743
Serious AEs
79.3%
Results posted
Aug 2014
Primary outcome: Primary: Overall Survival (Percentage of Participants Alive) — 64.3; 70.3 percentage of patients — p=0.180

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
cisplatin (Drug); Standard fractionation RT (Radiation); Accelerated fractionation radiation therapy (Radiation); Conventional surgery for select patients (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Radiation Therapy Oncology Group
Primary completion
Jun 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival (Percentage of Participants Alive)		 64.3; 70.3 0.180
SECONDARY
Local-regional Failure (Percentage of Participants With Local-regional Failure)		 25.5; 28.7 0.76
SECONDARY
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]		 25.6; 28.2 0.80
SECONDARY
Disease-free Survival (Percentage of Participants Alive Without Disease)		 51.4; 53.4 0.42
SECONDARY
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]		 55.8; 57.0 0.50
SECONDARY
Percentage of Participants With Toxicity Grade 3 or Higher		 83.7; 80.0; 21.1; 25.7 0.21
SECONDARY
Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year		 53.36; 53.63 0.92
SECONDARY
PSS-HN Public Eating Score - AUC at One Year		 65.81; 67.10 0.67
SECONDARY
PSS-HN Understandability of Speech Score - AUC at One Year		 90.48; 91.77 0.43
SECONDARY
Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year		 5.27; 5.19 0.39
SECONDARY
Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes		 — —
SECONDARY
Correlation of COX-2 With Outcomes		 — —

Summary

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
  • No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 50 mL/min
  • Calcium normal

Cardiovascular

  • No symptomatic coronary artery disease (angina)
  • No myocardial infarction within the past 6 months

Other

  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
  • No simultaneous primary tumors
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the head and neck except radioactive iodine therapy

Surgery

  • No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease
  • No radical or modified neck dissection
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00047008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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