Status:
COMPLETED
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
Lead Sponsor:
Hong Kong Nasopharyngeal Cancer Study Group Limited
Collaborating Sponsors:
The Hong Kong Anti-Cancer Society
hong Kong Cancer Fund
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The objectives of this clinical study are threefold: 1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from addi...
Detailed Description
1. primary objectives include 1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF) 2. comparing inductio...
Eligibility Criteria
Inclusion
- histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
- non-keratinizing or undifferentiated type
- stage III-IVB (by AJCC/UICC 6th edition)
- ECOG Performance status less or equal to 2
- Marrow: WBC \>= 4 and platelet \>=100
- Renal: creatinine clearance \>=60
- Informed consent
Exclusion
- Primary treatment with palliative intent
- WHO type I squamous cell carcinoma or adenocarcinoma
- Evidence of distant metastases
- Patient is pregnant or lactating
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
803 Patients enrolled
Trial Details
Trial ID
NCT00379262
Start Date
September 1 2006
End Date
December 1 2018
Last Update
August 7 2019
Active Locations (7)
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1
Cancer Center, Sun Yat Sen University
Guangzhou, China
2
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
3
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, China
4
Department of Clinical Oncology, Princess Margaret Hospital
Hong Kong, China