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Phase II study: Response adapted radiation therapy after induction chemotherapy in stage II-IVA nasopharyngeal carcinoma

Phase II study: Response adapted radiation therapy after induction chemotherapy in stage II-IVA nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180831004
Enrollment
138
Registered
2018-08-31
Start date
2018-09-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Due to the reports of radiation dose reduction in clinical response to induction chemotherapy of NPC patients are scarce. Therefore&#44

Interventions

The patients were divided in two groups after receive neoadjuvant chemotherapy
1. The patients with stable disease(SD) and progressive disease(PD) 2. The patients with complete response(CR) and partial response (PR) Radiotherapy dose: 1. CR and PR group 66/60/50 Gy&#44
2.SD and PD group 70/66/54 Gy
Response adapted radiation therapy after induction chemotherapy in stage II&#45
IVA NPC

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO I-III, Stage II-IVA (AJCC staging 2017) 2. Initial detectable pretreatment EBV> 1,500 or undetectable pretreatment EBV 3. No previous head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies 4. ≥ 18 years of age 5. Karnofsky performance scale ≥ 70 6. Acceptable laboratory investigation: WBC ≥ 3,000/μl, platelets ≥ 100,000/μl; serum creatinine ≤ 1.6 mg/dl or creatinine clearance ≥ 60 ml/min using the following formula: Estimated Creatinine Clearance = [140 – age (y)] x Body weight (kg) x 0.85 if female 72 Serum creatinine (mg/dl) 7. Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment 8. Signed study-specific informed consent form prior to study entry

Exclusion criteria

Exclusion criteria: 1. Stage I and IVB 2. Previous irradiation for head and neck tumor ≤ 6 months prior to study entry 3. Prior chemotherapy ≤ 6 months to study entry 4. Patients on any other experimental therapeutic cancer treatment 5. Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years 6. Active untreated infection 7. Major medical or psychiatric illness, which would interfere with either completion of therapy or follow-up or with full and complete understanding of the risks and potential complications of the therapy 8. Pregnant women

Design outcomes

Primary

MeasureTime frame
Locoregional failure free survival (LRFFS) 2 years MRI/CT scan a and physical examination

Secondary

MeasureTime frame
PFS, DMFS and OS 2yr MRI/CT scan a and physical examination,acute and late toxicities 2yr Common Terminology Criteria for Adverse Events v4.03(CTCEA),EBV DNA response for prediction of PFS,OS and DMFS 2yr MRI/CT scan a and physical examination

Contacts

Public ContactChawalit Lertbutsayanukul

none

wisutiyano@gmail.com0800524334

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026