Trial | NCT03175939  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    263
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.
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 Started
Apr 01
1998
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2014
Last Update
Jun 05
2017

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

CCRT alone Experimental

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

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
No Results Posted