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Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

Information source: Hospital Authority, Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasopharyngeal Neoplasms; Carcinoma, Squamous Cell

Intervention: Conventional RT (Procedure); Accelerated RT (Procedure); Cisplatin (Drug); 5-fluorouracil (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Hospital Authority, Hong Kong

Official(s) and/or principal investigator(s):
Anne WM Lee, Dr, Principal Investigator, Affiliation: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

Summary

To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.

Clinical Details

Official title: Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma

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

Primary outcome: Failure free survival rate

Secondary outcome:

Overall survival rate

Disease-specific survival rate

Complication-free rates

Eligibility

Minimum age: N/A. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Undifferentiated or non-keratinizing carcinoma

- Tumor staged as T3-4 AND N0-1

- 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

Locations and Contacts

Pamela Youde Nethersole Eastern Hospital, Hong Kong, China

Prince of Wales Hospital, Hong Kong, China

Queen Elizabeth Hospital, Hong Kong, China

Queen Mary Hospital, Hong Kong, China

Tuen Mun Hospital, Hong Kong, China

Additional Information

HAREC Clinical Trial Registry

Starting date: July 1999
Last updated: June 14, 2011

Page last updated: August 23, 2015

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