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

Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Cisplatin; Drug: 5-FU

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)

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: CDDP; Drug: 5-FU; 5-FU IV 24 hours continuous infusion; Other Names: 5-fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant-metastasis-free survival	percentage of patients who survived and has no distant metastasis	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	percentage of patients who survived	5 years
disease-free survival	percentage of patients who survived and had no disease recurrence	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 1998
• Primary Completion (Actual): December 31, 2008
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: adjuvant chemotherapy; NPC
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Cisplatin; Fluorouracil
• Other Study ID Numbers: NPC9801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No