Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

NCT05979961 | Recruiting Phase 3 DMC

• 1 other identifier: 2022-FXY-298
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Induction Chemotherapy; Concurrent Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progress-free survival(PFS)

  defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (5)

• Overall survival(OS)

  3 years

• Locoregional progression

  3 years

• Distant progression

  3 years

• Overall response rate

  16 weeks after completion of concurrent chemoradiotherapy

• Incidence of acute and late toxicity

  3 years

Study Arms (2)

IMRT and concurrent cisplatin

EXPERIMENTAL

Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.

Radiation: IMRT and concurrent cisplatin

Induction chemotherapy+IMRT and concurrent cisplatin

ACTIVE COMPARATOR

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.

Radiation: IMRT and concurrent cisplatin; Drug: gemcitabine and cisplatin (Induction chemotherapy)

Interventions

IMRT and concurrent cisplatin RADIATION

Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)

IMRT and concurrent cisplatin; Induction chemotherapy+IMRT and concurrent cisplatin

gemcitabine and cisplatin (Induction chemotherapy) DRUG

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy

Induction chemotherapy+IMRT and concurrent cisplatin

Eligibility Criteria

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

You may qualify if:

• Age 18-70 years old.
• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
• Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
• ECOG Performance status less or equal to 1.
• Male and no pregnant female.
• Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
• Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN.
• Adequate renal function: creatinine clearance ≥ 60 ml/min.
• Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

• Patients have evidence of relapse or distant metastasis.
• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
• Treatment with palliative intent.
• History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
• Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Tongji Hospital: collaborator
• Guangzhou Panyu Central Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• Cancer Hospital of Guizhou Province: collaborator

Study Sites (8)

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528499, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Cancer Hospital of Guizhou Province

Guiyang, Guizhou, China

NOT YET RECRUITING

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;

Wuhan, Hubei, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated; Gemcitabine; Cisplatin; Induction Chemotherapy

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)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Drug Therapy; Remission Induction

Central Study Contacts

Hai-Qiang Mai

CONTACT

862087343643; maihq@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (8)