Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

NCT ID: NCT05304468

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2029-10-29

Brief Summary

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

Detailed Description

To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduced-dose group

After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.

Group Type: EXPERIMENTAL

IMRT

Intervention Type: RADIATION

Patients in experimental group received reduced dose IMRT

induction chemotherapy

Intervention Type: DRUG

cisplatin-based induction chemotherapy for two cycles

cisplatin concurrent chemotherapy

Intervention Type: DRUG

cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Standard dose group

After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.

Group Type: ACTIVE_COMPARATOR

IMRT

Intervention Type: RADIATION

Patients in experimental group received reduced dose IMRT

induction chemotherapy

Intervention Type: DRUG

cisplatin-based induction chemotherapy for two cycles

cisplatin concurrent chemotherapy

Intervention Type: DRUG

cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Interventions

IMRT

Patients in experimental group received reduced dose IMRT

Intervention Type: RADIATION

induction chemotherapy

cisplatin-based induction chemotherapy for two cycles

Intervention Type: DRUG

cisplatin concurrent chemotherapy

cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).

2. Stage II-III（8thAJCC/UICC staging system)

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<1.5 x ULN；TBIL<1.5×ULN

7. CCR≥60ml/min or Cr<1.5×ULN

8. CR/PR and EBVDNA undetectable after induction chemotherapy

9. 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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hai-Qiang Mai,MD,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hai Qiang Mai, Dr

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2022-FXY-017

Identifier Type: -

Identifier Source: org_study_id