Phase 2 N=25 Treatment

High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00052429 ↗

Enrolled (actual)

Serious AEs

76.0%

Results posted

Feb 2016

Primary outcome: Primary: Survival Rate of Patients — 33 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cisplatin (Drug); fluorouracil (Drug); adjuvant therapy (Procedure); radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival Rate of Patients	33	—
PRIMARY Local Control of Participants	91; 91; 91; 89	—

Summary

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed nasopharyngeal cancer
Stage II-IVB
Newly diagnosed
No distant metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm^3
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8 g/dL

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN
AST no greater than 2.5 times ULN

Renal

Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min
Calcium no greater than 11.5 mg/dL

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Medically able to tolerate a definitive course of radiotherapy and the necessary immobilization
No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for this diagnosis
More than 3 years since other prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for this diagnosis
More than 3 years since other prior radiotherapy
No prior radiotherapy to the head and neck region

Surgery

Not specified

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00052429). 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.