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Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma


N/A
N/A
70 Years
Open (Enrolling)
Both
Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell

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Trial Information

Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma


Inclusion Criteria:



- Undifferentiated or non-keratinizing carcinoma

- Tumor staged as N2-3

- No evidence of distant metastasis M0

- Performance status:0-2

- Marrow: WBC >= 4 and platelet >= 100

- Renal: creatinine clearance >= 60

- Informed consent

Exclusion Criteria:

- WHO type I squamous cell carcinoma or adenocarcinoma

- Age >= 70

- Palliative intent or tumor extent mandating AP opposing facio-cervical fields

- 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

- Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT
treatment volume

- Previous chemotherapy

- Patient is pregnant or lactating

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Failure free survival rate

Outcome Time Frame:

5 year

Principal Investigator

Wai Hon LAU, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, Queen Elizabeth Hospital

Authority:

Hong Kong: Ethics Committee

Study ID:

L/M-77 TO PYH08/79

NCT ID:

NCT00563927

Start Date:

March 1999

Completion Date:

October 2009

Related Keywords:

  • Nasopharyngeal Neoplasms
  • Carcinoma, Squamous Cell
  • Nasopharyngeal Carcinoma
  • T1-4N2-3M0
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Nasopharyngeal Neoplasms

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