Skip to main content
OpenTrials
Completed

NCT Number: NCT00379262

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Center, Sun Yat Sen University, Guangzhou, China

Loading trial locations.

About this study

  • primary objectives include
  • comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
  • comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
  • comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
  • secondary objectives include
  • comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
  • Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles

Other names: Xeloda

Adjuvant chemotherapy using PF (5-Fluorouracil )

Drug

Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles

Induction chemotherapy using PF (5-Fluorouracil)

Drug

Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles

Primary outcomes

  1. 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

  2. Overall Survival, defined as the time to death due to any cause, at 5-year.

    Time frame: 5 years

Secondary outcomes

  1. overall Failure-Free Rate, defined as time to failure at any site)

    Time frame: 5 years

  2. Loco-regional Failure-Free Rate, defined as time to local or nodal failure)

    Time frame: 5 years

  3. Distant Failure-Free Rate, defined as time to distant failure)

    Time frame: 5 years

  4. Incidence of chemotherapy toxicity and acute RT toxicity grade > 3

    Time frame: treatment

  5. Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Other

Collaborators

  • The Hong Kong Anti-Cancer Society
  • hong Kong Cancer Fund

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2017
Study completion
2018
First posted
Sep 21, 2006
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.