Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )Drug: Induction chemotherapy using PF (5-Fluorouracil)
- Registration Number
- NCT00379262
- Lead Sponsor
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Brief Summary
The objectives of this clinical study are threefold:
1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
- Detailed Description
1. primary objectives include
1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
2. secondary objectives include
1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 803
- histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
- non-keratinizing or undifferentiated type
- stage III-IVB (by AJCC/UICC 6th edition)
- ECOG Performance status less or equal to 2
- Marrow: WBC >= 4 and platelet >=100
- Renal: creatinine clearance >=60
- Informed consent
- Primary treatment with palliative intent
- WHO type I squamous cell carcinoma or adenocarcinoma
- Evidence of distant metastases
- Patient is pregnant or lactating
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1A Adjuvant chemotherapy using PF (5-Fluorouracil ) Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy 1B Adjuvant chemotherapy using PF (5-Fluorouracil ) Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy 2A Induction chemotherapy using PF (5-Fluorouracil) Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy 2B Induction chemotherapy using PF (5-Fluorouracil) Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy 3B Capecitabine Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy 3A Capecitabine Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy
- Primary Outcome Measures
Name Time Method Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year. 5 years Overall Survival, defined as the time to death due to any cause, at 5-year. 5 years
- Secondary Outcome Measures
Name Time Method overall Failure-Free Rate, defined as time to failure at any site) 5 years Loco-regional Failure-Free Rate, defined as time to local or nodal failure) 5 years Distant Failure-Free Rate, defined as time to distant failure) 5 years Incidence of chemotherapy toxicity and acute RT toxicity grade > 3 treatment Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3) 5 years
Trial Locations
- Locations (7)
Cancer Center, Sun Yat Sen University
🇨🇳Guangzhou, China
Department of Clinical Oncology, Queen Mary Hospital
🇨🇳Hong Kong, China
Department of Clinical Oncology, Tuen Mun Hospital
🇨🇳Hong Kong, China
Department of Clinical Oncology, Prince of Wales Hospital
🇨🇳Hong Kong, China
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
🇨🇳Hong Kong, China
Department of Clinical Oncology, Queen Elizabeth Hospital
🇨🇳Hong Kong, China
Department of Clinical Oncology, Princess Margaret Hospital
🇨🇳Hong Kong, China