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ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT05062005

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Induction Chemotherapy+Chemoradiotherapy

Group Type OTHER

Induction Chemotherapy

Intervention Type DRUG

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.

Concurrent Chemotherapy

Intervention Type DRUG

Cisplatin 100 mg/m², Q3w.

Definitive Radiotherapy

Intervention Type RADIATION

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

Chemoradiotherapy

Group Type OTHER

Concurrent Chemotherapy

Intervention Type DRUG

Cisplatin 100 mg/m², Q3w.

Definitive Radiotherapy

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type DRUG

Concurrent Chemotherapy

Cisplatin 100 mg/m², Q3w.

Intervention Type DRUG

Definitive Radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Chen Yong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuang Wu, PHD

Role: CONTACT

Phone: +862087755766

Email: [email protected]

Facility Contacts

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Shuang Wu, PHD

Role: primary

Other Identifiers

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NCICCRTvCRT

Identifier Type: -

Identifier Source: org_study_id