Trial | NCT03015727  Report issue

Title

Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    docetaxel cisplatin ...

  • Study Participants

    440
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
Study Started
Dec 31
2016
Primary Completion
Dec 31
2022
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Jan 10
2017
Estimate

Drug Docetaxel

3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.

  • Other names: DOC

Drug Cisplatin

3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.

  • Other names: DDP

Radiation IMRT/TOMO

intensity modulated radiation therapy or tomotherapy

Drug Chemotherapy

2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.

  • Other names: concurrent chemotherapy

IC+RT group Experimental

3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.

IC+CCRT group Active Comparator

3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.

Criteria 

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing carcinoma.
Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
No evidence of distant metastasis (M0)
Performance status: KPS>70
With normal liver function test (ALT, AST <1.5ULN)
Renal: creatinine clearance >60ml/min
Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
With controlled blood glucose for diabetes patients
Written informed consent
satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

WHO type I squamous cell carcinoma or adenocarcinoma
Age >65 or <18
With a history of renal disease
Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
Patient is pregnant or lactating
Peripheral neuropathy
Emotional disturbance
No Results Posted