Radiation Therapy Alone Compared to Radiation Therapy Plus Chemotherapy in Treating Patients With Previously Untreated Cancer of the Nasopharynx
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is more effective than radiation therapy plus chemotherapy in treating cancer of the nasopharynx.
PURPOSE: This randomized phase III trial is studying how well radiation therapy and chemotherapy works compared to radiation therapy alone in treating patients with previously untreated cancer of the nasopharynx.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer |
- Clinical response [ Designated as safety issue: No ]
- Distant metastases [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 1998 |
OBJECTIVES:
- Compare the clinical response, distant metastases, disease-free survival, and overall survival in patients with previously untreated, locally advanced, nonmetastatic nasopharyngeal cancer treated with radiotherapy alone vs concurrent chemoradiotherapy followed by adjuvant chemotherapy.
OUTLINE: This is a randomized study.
Patients are randomized to receive radiotherapy alone (arm I) or concurrent chemoradiotherapy followed by adjuvant chemotherapy (arm II).
- Arm I: Patients receive radiotherapy once daily 5 times a week for 7 weeks.
- Arm II: Patients receive cisplatin IV over 6-8 hours for 4 consecutive days every 3 weeks for 3 courses. Concurrent radiotherapy is given once daily 5 times a week over the 7 week treatment period. This chemoradiotherapy is followed 3 weeks later by adjuvant chemotherapy. Patients receive cisplatin IV and fluorouracil IV over 6-8 hours for 4 consecutive days every 4 weeks for 3 courses.
Patients are followed every 4 months for the first year, every 6 months for the next 2 years, and then annually thereafter until death.
PROJECTED ACCRUAL: A minimum of 200 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed nasopharyngeal cancer that is previously untreated WHO Type III
- Stage III/IV (T3-4 Nx M0 or Tx N2-3 M0) confirmed by CT PNS
- No evidence of distant metastases detected on chest x-ray, bone scan, and liver ultrasound
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- SAP and SGOT less than 2 times upper limit of normal
- Bilirubin less than 1.4 mg/dL
Renal:
- Creatinine less than 1.6 mg/dL
- Creatinine clearance greater than 50 mL/min
Other:
- No other malignant disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- See Disease Characteristics
- No concurrent aminoglycoside antibiotics
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003637 History of Changes |
| Other Study ID Numbers: | CDR0000066722, NMRC-SQNP01, EU-98047 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Nasopharyngeal Neoplasms Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013