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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


N/A
18 Years
70 Years
Not Enrolling
Both
Nasopharyngeal Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

5-year

Principal Investigator

Anne WM Lee, Cos

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

Authority:

Hong Kong: Ethics Committee

Study ID:

HKEC-2006-120

NCT ID:

NCT00577057

Start Date:

September 2006

Completion Date:

August 2013

Related Keywords:

  • Nasopharyngeal Neoplasms
  • Nasopharyngeal Carcinoma
  • Stage III - IVB
  • Neoplasms
  • Nasopharyngeal Neoplasms

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