A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Conventional chemotherapy
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Shanghai Proton and Heavy Ion Center
- Enrollment
- 384
- Locations
- 14
- Primary Endpoint
- Progression-free survival
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
Detailed Description
This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m\^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m\^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.
Investigators
Lin Kong
Consultant doctor, chair of head and neck cancer
Shanghai Proton and Heavy Ion Center
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 and ≤ 70 years
- •Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III
- •With distant metastasis
- •With measurable lesions that can be detected by imaging studies
- •Achieving PR (partial response) after 4 cycles of conventional chemotherapy
- •Life expectancy ≥ 6 months
- •ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses
- •Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \> 2000/mm\^3; PLT (platelet count) \> 100,000/mm\^3; total bilirubin \< 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) \< 1.5 ULN (upper limit of normal); SCr (serum creatinine) \< 1.5mg/dl; CCR (creatinine clearance rate) \> 60ml/min
- •Willing to accept adequate contraception for women with childbearing potential
- •Ability to understand character and individual consequences of the clinical trial
Exclusion Criteria
- •Received previous treatment for metastatic disease
- •Pregnant or lactating women
- •A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years
- •Refusal of the patient to participate into the study
Arms & Interventions
Conventional chemotherapy
Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred.
Intervention: Conventional chemotherapy
Maintenance chemotherapy 1
Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.
Intervention: Conventional chemotherapy
Maintenance chemotherapy 1
Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.
Intervention: Maintenance chemotherapy 1
Maintenance chemotherapy 2
Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy.
Intervention: Conventional chemotherapy
Maintenance chemotherapy 2
Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy.
Intervention: Maintenance chemotherapy 2
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: From the time point the patients are included in the study, median of 3 years.
Secondary Outcomes
- Overall survival(From the time point the patients are included in the study, median of 3 years.)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03(From the time point the patients are included in the study, median of 3 years.)