Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

NCT03427359 | Completed Phase 2

• 1 other identifier: O1-HongKongShenzhen
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment of locally advanced nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; induction chemotherapy; cisplatin; capecitabine; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• PFS (progression free survival)

  progression free survival

  From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Study Arms (1)

experimental arm

EXPERIMENTAL

Induction chemotherapy: capecitabine tablet 1000mg/m2 po bid from day1 to 14,cisplatin injection 80mg/m2 iv day1,every 3 weeks for a total of 3 cycles. Then followed by concurrent chemoradiotherapy with cisplatin injection 100mg/m2 iv every 3 weeks for a total of 2 cycles.

Drug: cisplatin, capecitabine

Interventions

cisplatin, capecitabine DRUG

Experimental arm patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.

Also known as: chemoradiotherapy

experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological confirmed nasopharyngeal carcinoma.
• Staged as III to IVB.
• years old.
• Performance status ≤2.
• No previous chemotherapy or radiotherapy.
• No concurrent malignancies or a history of other malignancies.
• Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L).
• Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min).
• Without serious co-morbidity.

You may not qualify if:

• Stage I-II or IVC.
• Allergic to cisplatin or capecitabine
• Age \<18 or \>75
• Performance Status \>2.
• Without adequate bone marrow or liver function or renal function.
• Severe co-morbidity and can not tolerate chemotherapy.
• Other conditions not suitable for the study on the discretion of charging doctor.

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin; Capecitabine; Chemoradiotherapy

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: February 9, 2018
• Study Start: January 22, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-01