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

This study has been terminated.
Sponsor:
Collaborators:
National Taiwan University Hospital
Tri-Service General Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201344
First received: September 13, 2005
Last updated: March 25, 2010
Last verified: June 2009
  Purpose
  • 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.

Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Cisplatin,5-FU,Leucovorin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • overall survival, relapse free survival,distant metastasis and local-regional control rates.

Secondary Outcome Measures:
  • toxicities of the two treatment methods.

Estimated Enrollment: 320
Study Start Date: November 1994
Estimated Study Completion Date: January 2000
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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201344

Locations
Taiwan
Veterans General Hospital-Taipei
Taipei, Taiwan, 112
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Tri-Service General Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Investigators
Principal Investigator: Kwan-Hwa Chi, MD, Taiwan cooperative oncology group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201344     History of Changes
Other Study ID Numbers: T1394
Study First Received: September 13, 2005
Last Updated: March 25, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Radiotherapy
Adjuvant chemotherapy
Chemtherapy
Nasopharyngeal Carcinoma

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Leucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014