Know Cancer

forgot password

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

Phase 3
70 Years
Not Enrolling
Nasopharyngeal Carcinoma

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival, relapse free survival,distant metastasis and local-regional control rates.

Principal Investigator

Kwan-Hwa Chi, MD,

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taiwan cooperative oncology group


Taiwan: Department of Health

Study ID:




Start Date:

November 1994

Completion Date:

January 2000

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Radiotherapy
  • Adjuvant chemotherapy
  • Chemtherapy
  • Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms