Clinical trial NCT00577057: Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
Official title: Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Neoplasms
Keywords: Nasopharyngeal Carcinoma
Stage III - IVB
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Hong Kong Nasopharyngeal Cancer Study Group Limited
First posted: 2007-12-19
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
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 (PF or PX, respectively) 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.


Eligibility criteria: Inclusion Criteria:

* Histologically proven nasopharyngeal carcinoma
* Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
* Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
* Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
* Liver scan if SGOT exceeds the institutional upper limit of normal
* Adequate marrow: WBC \> 4 and platelet \> 100
* Adequate renal function: creatinine clearance \> 60 ml/min.
* Satisfactory performance status: \> 2 by ECOG System.

Exclusion Criteria:

* WHO Type I squamous cell carcinoma or adenocarcinoma
* Age \> 70
* Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
* 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 five years.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

Primary outcomes:
measure: Progression-free survival
timeFrame: 5-year
measure: Overall Survival
timeFrame: 5-year
Secondary outcomes:
measure: Overall / Locoregional / Distant Failure Free Rate
timeFrame: 5-year
measure: Chemotherapy and RT toxicity
timeFrame: within 90 day from commencement of RT
measure: Late Toxicity
timeFrame: 5-year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Princess Margaret Hospital
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
name: Anne WM Lee, Cos
role: PRINCIPAL_INVESTIGATOR
References: