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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Anne W.M. Lee, F.R.C.R.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

Authority:

Hong Kong: Ethics Committee

Study ID:

NPC-0501 Trial

NCT ID:

NCT00379262

Start Date:

September 2006

Completion Date:

April 2017

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Carcinoma
  • Chemoradiotherapy
  • Accelerated Fractionation
  • Carcinoma
  • Nasopharyngeal Neoplasms

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