ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05062005
Collaborator
(none)
447
1
2
71.3
6.3

Study Details

Study Description

Brief Summary

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Induction Chemotherapy
  • Drug: Concurrent Chemotherapy
  • Radiation: Definitive Radiotherapy
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
447 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Anticipated Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
Aug 31, 2027
Anticipated Study Completion Date :
Aug 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Induction Chemotherapy+Chemoradiotherapy

Drug: Induction Chemotherapy
Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.

Drug: Concurrent Chemotherapy
Cisplatin 100 mg/m², Q3w.

Radiation: Definitive Radiotherapy
For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

Other: Chemoradiotherapy

Drug: Concurrent Chemotherapy
Cisplatin 100 mg/m², Q3w.

Radiation: Definitive Radiotherapy
For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

Outcome Measures

Primary Outcome Measures

  1. FFS (Failure-free Survival) [3 year]

    Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.

Secondary Outcome Measures

  1. OS (Overall Survival) [3 year]

    Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

  2. LRFS (Locoregional Recurrence-free Survival) [3 year]

    Defined as the time from randomization to local or regional recurrence. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence free. Patients not having an event will be censored at the date last seen alive.

  3. DMFS (Distant Metastasis-free Survival) [3 year]

    Defined as the time of randomization to the appearance of distant metastasis. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and metastasis free. Patients not having an event will be censored at the date last seen alive.

  4. AE (Adverse events) [3 year]

    Adverse events during the treatment period will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Late AE of radiotherapy will be assessed according to RTOG criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age 18-65 years old;

  2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;

  3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);

  4. No distant metastasis;

  5. Have not received anti-cancer treatment in the past;

  6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;

  7. Adequate hematologic, hepatic and renal function.

Exclusion Criteria:
  1. The purpose of treatment is palliative;

  2. Diagnosed with other malignant tumors at the same time;

  3. Malignant tumor history;

  4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;

  5. Combined serious illness.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guang Dong China 510080

Sponsors and Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chen Yong, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05062005
Other Study ID Numbers:
  • NCICCRTvCRT
First Posted:
Sep 30, 2021
Last Update Posted:
Sep 30, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2021