Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

• ClinicalTrials.gov Identifier: NCT02434614
• Recruitment Status: Unknown
• First Posted: May 5, 2015
• Last Update Posted: May 16, 2018
• Sponsor: Wei Jiang
• Collaborators: Wuzhou Red Cross Hospital; Guangxi Naxishan Hospital; LiuZhou People's Hospital; Guigang People's Hospital; Affiliated Hospital of Youjiang Medical University for Nationalities; Nanning Monority Hospital
• Information provided by (Responsible Party): Wei Jiang, Guilin Medical University, China

Tracking Information

• First Submitted Date: April 27, 2015
• First Posted Date: May 5, 2015
• Last Update Posted Date: May 16, 2018
• Study Start Date: March 2015
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2015)

Progression-free Survival [ Time Frame: 3 years ]

Progression-free survival is to first disease progression [local recurrence and/or distant metastasis] or death from any cause.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 30, 2015)

• Overall Survival [ Time Frame: 3 years ]
  Overall survival is from randomization to death of any cause or last follow-up.
• Locoregional Failure-free Survival [ Time Frame: 3 years ]
  Locoregional failure-free survival is from randomization to locoregional progression.
• Distant Failure-free Survival [ Time Frame: 3 years ]
  Distant failure-free survival is from randomization to first distant metastasis.
• Number of Participants with Adverse Events [ Time Frame: 3 years ]
  Incidence of acute and late toxicity

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
• Official Title: A Randomized Phase III Non-inferiority Study of Induction Chemotherapy Followed by IMRT Alone Versus Induction Chemotherapy Followed by IMRT Plus Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
• Brief Summary: Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally advanced NPC. However, most of these evidences of standard treatment for locoregionally advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve survival rates for patients with locoregionally advanced disease, but increased the severity of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose this randomized phase III non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in locoregionally advanced NPC during IMRT era.
• Detailed Description: Patients with with previously untreated non-metastatic newly histologically-confirmed non-keratinizing III-IVb NPC (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy followed by IMRT alone (investigational group) or induction chemotherapy followed by IMRT plus concurrent chemotherapy (control group). During induction chemotherapy, patients in both groups receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks. During radiotherapy, patients in investigational group received IMRT alone and patients in control group received IMRT, concurrently with weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. The primary endpoint is failure-free survival(FFS). Secondary clinical endpoints include overall survival (OS), locoregional failure-free survival (LRFFS), distant failure-free survival (DFFS) rates and toxic effects.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nasopharyngeal Carcinoma

Intervention

• Drug: Docetaxel,Cisplatin,Fluorouracil
  Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks.
  Other Name: No.
• Radiation: Intensity-modulated radiation therapy (IMRT)
  IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.
  Other Name: No.
• Drug: Cisplatin
  Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.
  Other Name: No.

Study Arms

• Experimental: Induction CT+IMRT alone
  Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone
  Interventions:

  • Drug: Docetaxel,Cisplatin,Fluorouracil
  • Radiation: Intensity-modulated radiation therapy (IMRT)
• Active Comparator: Induction CT+IMRT Combined Concurrent CT
  Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy
  Interventions:

  • Drug: Docetaxel,Cisplatin,Fluorouracil
  • Radiation: Intensity-modulated radiation therapy (IMRT)
  • Drug: Cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: May 10, 2018): 440
• Original Estimated Enrollment (submitted: April 30, 2015): 360
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); Tumor staged as III-IVb (according to the 7th AJCC edition); No pregnant female; Age between 18-70; Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL); Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase < 2.5 times higher than upper limit); Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Without radiotherapy or chemotherapy; Patients must give signed informed consent.

Exclusion Criteria:

Disease progression in the process of the treatment; The presence of uncontrolled life-threatening illness; History of previous radiotherapy or chemotherapy; Pregnancy or lactation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02434614
• Other Study ID Numbers: GLMU-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wei Jiang, Guilin Medical University, China
• Original Responsible Party: Same as current
• Current Study Sponsor: Wei Jiang
• Original Study Sponsor: Same as current

Collaborators

• Wuzhou Red Cross Hospital
• Guangxi Naxishan Hospital
• LiuZhou People's Hospital
• Guigang People's Hospital
• Affiliated Hospital of Youjiang Medical University for Nationalities
• Nanning Monority Hospital

Investigators

• Study Director: Wei Jiang, Ph.D.; Guilin Medical University Affiliated Hospital

• PRS Account: Guilin Medical University, China
• Verification Date: May 2018