Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Adjuvant chemotherapy using PF (5-Fluorouracil )
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Enrollment
- 803
- Locations
- 7
- Primary Endpoint
- Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objectives of this clinical study are threefold:
- 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.
- 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.
- 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.
Investigators
Dr. ANNE W M LEE
Consultant, Dept of Clinical Oncology, PYNEH
Hong Kong Nasopharyngeal Cancer Study Group Limited
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1A
Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy
Intervention: Adjuvant chemotherapy using PF (5-Fluorouracil )
1B
Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy
Intervention: Adjuvant chemotherapy using PF (5-Fluorouracil )
2A
Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy
Intervention: Induction chemotherapy using PF (5-Fluorouracil)
2B
Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy
Intervention: Induction chemotherapy using PF (5-Fluorouracil)
3A
Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy
Intervention: Capecitabine
3B
Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy
Intervention: Capecitabine
Outcomes
Primary Outcomes
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
Time Frame: 5 years
Overall Survival, defined as the time to death due to any cause, at 5-year.
Time Frame: 5 years
Secondary Outcomes
- Distant Failure-Free Rate, defined as time to distant failure)(5 years)
- 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)
- 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)