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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Cancer

Treatments: Radiation: Radiotherapy; Drug: Cisplatin; Drug: 5-FU

Study type: Interventional

Funder types: Other

Identifiers

NCT03175939

NPC9801

Details and patient eligibility

About

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.

Full 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)

Enrollment: 263 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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263 participants in 1 patient group

CCRT alone

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: 5-FU

Drug: Cisplatin