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Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03175939
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jia-Shing Wu, Sun Yat-sen University

Brief Summary:
This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancer Radiation: Radiotherapy Drug: Cisplatin Drug: 5-FU Phase 2

Detailed Description:
The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
Actual Study Start Date : April 1, 1998
Actual Primary Completion Date : December 31, 2008
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CCRT alone
External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
Radiation: Radiotherapy
External beam radiotherapy with curative intent, at least 66 Gy

Drug: Cisplatin
cisplatin IV injection over 3 hours
Other Name: CDDP

Drug: 5-FU
5-FU IV 24 hours continuous infusion
Other Name: 5-fluorouracil




Primary Outcome Measures :
  1. Distant-metastasis-free survival [ Time Frame: 5 years ]
    percentage of patients who survived and has no distant metastasis


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    percentage of patients who survived

  2. disease-free survival [ Time Frame: 5 years ]
    percentage of patients who survived and had no disease recurrence



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) biopsy-proven carcinoma of the nasopharynx,
  • (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
  • (3) normal renal function (Cr < 1.6 mg/dl),

Exclusion Criteria:

  • open-neck lymph node biopsy
  • previous chemotherapy or radiotherapy to the head and neck region
  • distant metastasis or other malignant diseases except skin cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175939


Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Skye Hung-Chun Cheng, M.D. Koo Foundation Sun Yat-Sen Cancer Center

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Responsible Party: Jia-Shing Wu, Attending Physician, M.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03175939     History of Changes
Other Study ID Numbers: NPC9801
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jia-Shing Wu, Sun Yat-sen University:
adjuvant chemotherapy
NPC

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents