Clinical trial NCT00379262: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Chemoradiotherapy
Accelerated Fractionation
Lead sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited
Sponsor class: OTHER
Collaborators: name: The Hong Kong Anti-Cancer Society
name: hong Kong Cancer Fund
First posted: 2006-09-21
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
timeFrame: 5 years
measure: Overall Survival, defined as the time to death due to any cause, at 5-year.
timeFrame: 5 years
Secondary outcomes:
measure: overall Failure-Free Rate, defined as time to failure at any site)
timeFrame: 5 years
measure: Loco-regional Failure-Free Rate, defined as time to local or nodal failure)
timeFrame: 5 years
measure: Distant Failure-Free Rate, defined as time to distant failure)
timeFrame: 5 years
measure: Incidence of chemotherapy toxicity and acute RT toxicity grade > 3
timeFrame: treatment
measure: Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat Sen University
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Prince of Wales Hospital
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Princess Margaret Hospital
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Queen Elizabeth Hospital
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Queen Mary Hospital
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Tuen Mun Hospital
Study officials:
affiliation: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
name: Anne W.M. Lee, F.R.C.R.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong
name: Roger K.C. Ngan, F.R.C.R
role: PRINCIPAL_INVESTIGATOR
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