Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study

NCT02187315 | Unknown Phase 2

• 1 other identifier: 20140501
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety

  5 year

Secondary Outcomes (1)

• Number of Participants with curative effect

  1 year

Study Arms (2)

Melodie group

EXPERIMENTAL

Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy

Device: Chrono-chemotherapy pump:Melodie; Drug: induction chemotherapy; Drug: cisplatin chrono-chemotherapy; Radiation: intensity-modulated radiation therapy

Routine-chemotherapy group

OTHER

Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Device: Routine intravenous drip; Drug: induction chemotherapy; Radiation: intensity-modulated radiation therapy; Drug: cisplatin routine-chemotherapy

Interventions

Chrono-chemotherapy pump:Melodie DEVICE

Melodie group

Routine intravenous drip DEVICE

Routine-chemotherapy group

induction chemotherapy DRUG

Melodie group; Routine-chemotherapy group

cisplatin chrono-chemotherapy DRUG

Melodie group

intensity-modulated radiation therapy RADIATION

Melodie group; Routine-chemotherapy group

cisplatin routine-chemotherapy DRUG

Routine-chemotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
• Karnofsky score≥70;
• Age 18-70 years old, male or female;
• No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment;
• To understand this study and sign informed consent form.

You may not qualify if:

• A distant metastasis;
• Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
• Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
• Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.

Sponsors & Collaborators

• Feng Jing: lead

Study Sites (1)

The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital

Guiyang, Guizhou, 550001, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Induction Chemotherapy; Radiotherapy, Intensity-Modulated

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)

Drug Therapy; Therapeutics; Remission Induction; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy

Central Study Contacts

Feng Jin, Professor

CONTACT

+86 13985124806; jinf8865@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guiyang Medical College

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: July 11, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

CN (1)