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

NCT02434614 | Unknown Phase 3 DMC

• 1 other identifier: GLMU-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 6

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

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

  3 years

Secondary Outcomes (4)

• Overall Survival

  3 years

• Locoregional Failure-free Survival

  3 years

• Distant Failure-free Survival

  3 years

• Number of Participants with Adverse Events

  3 years

Study Arms (2)

Induction CT+IMRT alone

EXPERIMENTAL

Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone

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

Induction CT+IMRT Combined Concurrent CT

ACTIVE COMPARATOR

Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy

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

Interventions

Docetaxel,Cisplatin,Fluorouracil DRUG

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.

Also known as: No.

Induction CT+IMRT Combined Concurrent CT; Induction CT+IMRT alone

Intensity-modulated radiation therapy (IMRT) RADIATION

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.

Also known as: No.

Induction CT+IMRT Combined Concurrent CT; Induction CT+IMRT alone

Cisplatin DRUG

Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.

Also known as: No.

Induction CT+IMRT Combined Concurrent CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wei Jiang: lead
• Wuzhou Red Cross Hospital: collaborator
• Guangxi Naxishan Hospital: collaborator
• LiuZhou People's Hospital: collaborator
• Guigang People's Hospital: collaborator
• Youjiang Medical College for Nationalities: collaborator
• Nanning Monority Hospital: collaborator

Study Sites (6)

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, Guangxi, China

Location

Guigang People's Hospital

Guigang, Guangxi, China

Location

Guangxi Naxishan Hospital

Guilin, Guangxi, China

Location

Liuzhou People's Hospital

Liuchow, Guangxi, China

Location

Nanning Monority Hospital

Nanning, Guangxi, China

Location

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

Location

Related Publications (1)

• Dai J, Zhang B, Su Y, Pan Y, Ye Z, Cai R, Qin G, Kong X, Mo Y, Zhang R, Liu Z, Xie Y, Ruan X, Jiang W. Induction Chemotherapy Followed by Radiotherapy vs Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):456-463. doi: 10.1001/jamaoncol.2023.6552.

  PMID: 38329737 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Docetaxel; CF regimen; Radiotherapy, Intensity-Modulated; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wei Jiang, Ph.D.

  Guilin Medical University Affiliated Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 5, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

CN (6)