A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients

NCT ID: NCT00201344

Last Updated: 2010-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-11-30
• Study Completion Date: 2000-01-31

Brief Summary

• To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
• To evaluate the toxicities of the two treatment methods.

Detailed Description

The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups, but disease free survival was prolonged in the maintenance arm and not in the induction arm. Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm. Many trials, designed several years ago, delivered single agent chemotherapy and were not particularly intensive. Most clinical trials were dealing with a heterogenous group of head and neck cancer patients. We felt that a better choice of adjuvant chemotherapy on cancers should include: (1) localized cancers with high metastatic potential following effective local treatment; (2) effective chemotherapy available; (3) chemotherapy should be intensive and effective enough to avoid the development of drug resistance. Of course, NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized, advanced staged disease.

If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate, decreasing the metastatic rate and local recurrence rate, then many NPC patients may benefit.

Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cisplatin,5-FU,Leucovorin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
• Original stage must be stage IV disease (M0)
• Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
• Performance status scale ECOG grade 0，1.
• Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance > 45ml/min if Creatinine > 1.5mg/dl.
• Patients must be younger than 70 year-old.
• Patients must give signed informed consent.

Exclusion Criteria

• Patients had progressive disease after radiotherapy
• Patients had evidence of distant metastasis.
• Patients had completed radiotherapy for more than 7 weeks.
• The presence of life-threatening illness
• History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
• Previous chemotherapy.
• Pregnancy.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Principal Investigators

Kwan-Hwa Chi, MD,

Role: PRINCIPAL_INVESTIGATOR

Taiwan cooperative oncology group

Locations

Veterans General Hospital-Taipei

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

T1394

Identifier Type: -

Identifier Source: org_study_id