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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00201344
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : March 26, 2010
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

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Cisplatin,5-FU,Leucovorin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
Study Start Date : November 1994
Study Completion Date : January 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Leucovorin




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201344


Locations
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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
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Principal Investigator: Kwan-Hwa Chi, MD, Taiwan cooperative oncology group
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ClinicalTrials.gov Identifier: NCT00201344    
Other Study ID Numbers: T1394
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: June 2009
Keywords provided by National Health Research Institutes, Taiwan:
Radiotherapy
Adjuvant chemotherapy
Chemtherapy
Nasopharyngeal Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Leucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances