Brief Title
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
Official Title
Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
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 adding
concurrent-adjuvant chemotherapy to radiation.
2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the
chemotherapy plan will maintain or improve further the chemotherapy benefits while
reducing the duration of hospital stay.
3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as
compared with conventional fractionation radiotherapy.
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 induction chemotherapy with Cisplatin + Capecitabine versus adjuvant
chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
3. comparing accelerated fractionation versus conventional fractionation (AF vs
CF)radiotherapy.
2. secondary objectives include
1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction
chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy
sequence.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
Secondary Outcome
overall Failure-Free Rate, defined as time to failure at any site)
Condition
Nasopharyngeal Carcinoma
Intervention
Capecitabine
Study Arms / Comparison Groups
1A
Description: Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
803
Start Date
September 2006
Completion Date
December 2018
Primary Completion Date
May 2017
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Anne W.M. Lee, F.R.C.R., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00379262
Organization ID
NPC-0501 Trial
Responsible Party
Principal Investigator
Study Sponsor
Hong Kong Nasopharyngeal Cancer Study Group Limited
Collaborators
The Hong Kong Anti-Cancer Society
Study Sponsor
Anne W.M. Lee, F.R.C.R., Principal Investigator, Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Verification Date
August 2019