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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-19

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced dose group

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.

Group Type EXPERIMENTAL

Intensity-modulated radiation therapy

Intervention Type RADIATION

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

Paclitaxel liposome

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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.

5-Fluorouracil

Intervention Type DRUG

Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.

Standard dose group

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.

Group Type EXPERIMENTAL

Intensity-modulated radiation therapy

Intervention Type RADIATION

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

Paclitaxel liposome

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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.

5-Fluorouracil

Intervention Type DRUG

Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.

Interventions

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Intensity-modulated radiation therapy

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

Intervention Type RADIATION

Paclitaxel liposome

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

Intervention Type DRUG

Cisplatin

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.

Intervention Type DRUG

5-Fluorouracil

Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No