Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hong Kong Nasopharyngeal Cancer Study Group Limited
Sponsor:
Collaborators:
The Hong Kong Anti-Cancer Society
hong Kong Cancer Fund
Information provided by (Responsible Party):
Dr. ANNE W M LEE, Hong Kong Nasopharyngeal Cancer Study Group Limited
ClinicalTrials.gov Identifier:
NCT00379262
First received: September 20, 2006
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Capecitabine
Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )
Drug: Induction chemotherapy using PF (5-Fluorouracil)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hong Kong Nasopharyngeal Cancer Study Group Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Overall Survival, defined as the time to death due to any cause, at 5-year. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall Failure-Free Rate, defined as time to failure at any site) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Loco-regional Failure-Free Rate, defined as time to local or nodal failure) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Distant Failure-Free Rate, defined as time to distant failure) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of chemotherapy toxicity and acute RT toxicity grade > 3 [ Time Frame: treatment ] [ Designated as safety issue: Yes ]
  • Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 798
Study Start Date: September 2006
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1A
Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy
Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )
Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles
Experimental: 1B
Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy
Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )
Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles
Experimental: 2A
Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy
Drug: Induction chemotherapy using PF (5-Fluorouracil)
Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
Experimental: 2B
Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy
Drug: Induction chemotherapy using PF (5-Fluorouracil)
Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
Experimental: 3A
Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy
Drug: Capecitabine
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
Other Name: Xeloda
Experimental: 3B
Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy
Drug: Capecitabine
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
Other Name: Xeloda

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379262

Contacts
Contact: Anne W.M. Lee, FRCR (HK) 852-25954173 awmlee@ha.org.hk

Locations
China
Cancer Center, Sun Yat Sen University Recruiting
Guangzhou, China
Contact: T.X. Lu, M.D.    86-20 87343372    lutaix@public.guangzhou.gd.cn   
Principal Investigator: T.X. Lu, M.D.         
Department of Clinical Oncology, Queen Elizabeth Hospital Recruiting
Hong Kong, China
Contact: Roger K.C. Ngan, F.R.C.R.    852-29586255    ngankc@ha.org.hk   
Principal Investigator: Roger K.C. Ngan, F.R.C.R.         
Department of Clinical Oncology, Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Dora Kwong, F.R.C.R    852-28554521    dlwkwong@hkucc.hku.hk   
Principal Investigator: Dora Kwong, F.R.C.R.         
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Anthony Chan, F.R.C.R.    852-26322989    anthonytcchan@cuhk.edu.hk   
Principal Investigator: Anthony Chan, F.R.C.R         
Department of Clinical Oncology, Princess Margaret Hospital Not yet recruiting
Hong Kong, China
Contact: Ashley Cheng, F.R.C.R.    852-29902803    ackcheng@ha.org.hk   
Principal Investigator: Ashley Cheng`, F.R.C.R         
Department of Clinical Oncology, Tuen Mun Hospital Recruiting
Hong Kong, China
Contact: Stewart Y. Tung, F.R.C.R    852-24685098    tungys@ha.org.hk   
Principal Investigator: Stewart Y. Tung, F.R.C.R.         
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, China
Contact: Anne W.M. Lee, F.R.C.R.    852-25954173    awmlee@ha.org.hk   
Principal Investigator: Anne M.W. Lee, F.R.C.R.         
Sponsors and Collaborators
Hong Kong Nasopharyngeal Cancer Study Group Limited
The Hong Kong Anti-Cancer Society
hong Kong Cancer Fund
Investigators
Principal Investigator: Anne W.M. Lee, F.R.C.R. Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Principal Investigator: Roger K.C. Ngan, F.R.C.R Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong
  More Information

Publications:
Greene FL, et al. AJCC Cancer Staging Handbook from the AJCC cancer staging manual, 6th ed. New York: Springer, 2002.
Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.

Responsible Party: Dr. ANNE W M LEE, Consultant, Dept of Clinical Oncology, PYNEH, Hong Kong Nasopharyngeal Cancer Study Group Limited
ClinicalTrials.gov Identifier: NCT00379262     History of Changes
Other Study ID Numbers: NPC-0501 Trial
Study First Received: September 20, 2006
Last Updated: September 5, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hong Kong Nasopharyngeal Cancer Study Group Limited:
Nasopharyngeal Carcinoma
Chemoradiotherapy
Accelerated Fractionation

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Fluorouracil
Capecitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014