Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma

Sun Yat-sen University215 enrolled

Overview

To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.

To explore the 2 year PFS of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by reduced-dose radiation and cisplatin. The enrolled patients will receive 2 cycles of TPF regimen induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be delivered by 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. If radiographic SD/PD or EBV DNA\>0 after induction chemotherapy, the patients will receive a total of 70 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. The included patients will be treated with 2 cycles of TPF regimen induction chemotherapy and 60Gy IMRT combined with cisplatin concurrent chemotherapy. The TPF regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-Fu 3750mg/m2 civ120h, with a total of two cycles. Concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. The third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after IMRT finished.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

215

Conditions

Nasopharyngeal Carcinoma

Interventions

Intensity-modulated radiation therapyRADIATION

Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy

Paclitaxel liposomeDRUG

Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.

CisplatinDRUG

Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pathological diagnosis of NPC(WHO II or III). 2. Stage III（8thAJCC/UICC staging system) and pretreatment EBVDNA\<4000opies/ml. 3. Aged 18-70 years。 4. ECOG = 0-1。 5. HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L. 6. ALT,AST\<2.5 fold of ULN；TBIL\<2.0×ULN。 7. CCR≥60ml/min or Cr\<1.5×ULN。 8. Signed informed consent Exclusion Criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Age \<18 or \>70years. 3. Treatment with palliative intent. 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 5. Pregnancy or lactation. 6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). 7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

Locations (1)

Hai Qiang Mai

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

PFS(progression free survival)

Defined from date of registration to date of first documentation of progression and/or distant metastasis,or death due to any cause. The primary study population for this endpoint is patients who were confirmed post-induction CR /PR and EBV DNA=0 and subsequently received 60Gy radiation therapy.

Time frame: 2 years

Secondary Outcomes

Overall Survival(OS)

Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.

Time frame: 2 years

Locoregional relapse-free survival(LRFS)

Defined from date of registration to date of first documentation of locoregional relapse or until the date of the last follow-up visit.

Time frame: 2 years

Distant metastasis-free survival(DMFS)

Defined from date of registration to date of first documentation of distant metastases or until the date of the last follow-up visit.

Time frame: 2 years

Overall response rate

Tumour response rate was classified according to RECIST, version 1.1

Time frame: 2 years

Incidence of acute toxicity

Numbers of patients of treatment-related adverse events as assessed by CTCAE v4.0.

Time frame: 2 years

Incidence of late toxicity

Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

Data from ClinicalTrials.gov

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