A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients
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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 |
- overall survival, relapse free survival,distant metastasis and local-regional control rates.
- toxicities of the two treatment methods.
| Estimated Enrollment: | 320 |
| Study Start Date: | November 1994 |
| Estimated Study Completion Date: | January 2000 |
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 |
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| Taiwan | |
| Veterans General Hospital-Taipei | |
| Taipei, Taiwan, 112 | |
| 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 |
Adjuvants, Immunologic Cisplatin Leucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013