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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Paclitaxel liposome; Radiation: Intensity-modulated radiation therapy; Drug: Cisplatin; Drug: 5-Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT03668730

B2018-020-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 215 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Reduced dose group

Experimental group

Description:

After 2 cycles of induction chemotherapy with Paclitaxel Liposome, Cisplatin and 5-Fluorouracil, patients undergo low-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive cisplatin once per three week for 3 cycles.

Treatment:

Drug: Paclitaxel liposome

Drug: 5-Fluorouracil

Radiation: Intensity-modulated radiation therapy

Drug: Cisplatin

Standard dose group

Experimental group

Description:

After 2 cycles of induction chemotherapy with Paclitaxel Liposome,Cisplatin and 5-Fluorouracil, patients undergo standard-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (33 fractions). Patients also receive cisplatin once per three week for 3 cycles.

Treatment:

Drug: Paclitaxel liposome

Drug: 5-Fluorouracil

Radiation: Intensity-modulated radiation therapy

Drug: Cisplatin