The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

NCT01817023 | Unknown Phase 3 DMC

• 1 other identifier: CH-HN-003
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; current chemotherapy; intensity-modulated radiotherapy; low-risk

Outcome Measures

Primary Outcomes (1)

• overall survival

  according to the recruitment, a interrim analysis will done in July, 2019, if there is inferior finding of RT alone group, the study will premature terminate

  5 years

Secondary Outcomes (2)

• Acute and late toxicities

  5years

• 3 year Progression-free survival (PFS)

  5year

Study Arms (2)

RT alone

EXPERIMENTAL

SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume

Radiation: SIB-IMRT

CCRT group

ACTIVE COMPARATOR

SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume and cisplatin 100mg/m2 was given at d1, d22,d43 during radiotherapy.

Radiation: SIB-IMRT; Drug: Cisplatin

Interventions

SIB-IMRT RADIATION

SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume

CCRT group; RT alone

Cisplatin DRUG

Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.

CCRT group

Eligibility Criteria

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

You may qualify if:

• Histopathological proven non-keratin nasopharyngeal carcinoma
• AJCC 7th edition stage III/IVM0, without any one of following factors: node size \>6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node \>4 cm
• Life expectancy≥6 months
• Adequate renal function, defined as follows: Serum creatinine \< 2 x institutional upper limit of normal(ULN) within 2 weeks prior to registration or creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CCrmale)
• The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Severe, active co-morbidity
• Treatment planning does not meet the requirement of prescription dose.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (6)

Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Tongji hospital, Huazhong University of Science & Technology

Wuhan, Hubei, 430032, China

RECRUITING

Jiangxi province cancer hospital

Nanchang, Jiangxi, 330029, China

NOT YET RECRUITING

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Li Gao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junlin YI, MD

CONTACT

861087788504; yijunlin1969@163.com

Kai Wang, MD

CONTACT

8613910741366; kaiwang2007@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: central investigator organization digital randomize
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chairman， Department of Radiation Oncology, Cancer hospital

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: April 1, 2013
• Primary Completion: July 30, 2019
• Study Completion: March 30, 2021
• Last Updated: January 29, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)