Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT02460419 |
Recruitment Status :
Completed
First Posted : June 2, 2015
Last Update Posted : October 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Carcinoma | Drug: capecitabine Other: Best supportive care (BSC) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study. |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | May 2020 |
Actual Study Completion Date : | May 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: maintenance capecitabine
maintenance capecitabine plus best supportive care(BSC)
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Drug: capecitabine
capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: Xeloda Other: Best supportive care (BSC) Best supportive care and following-up every 6-8 weeks |
best supportive care
Best supportive care and following-up every 6-8 weeks
|
Other: Best supportive care (BSC)
Best supportive care and following-up every 6-8 weeks |
- progression-free survival [ Time Frame: up to 6 years ]the time from randomization to the progression of disease
- overall survival [ Time Frame: up to 6 years ]the time from randomization to death
- duration of response [ Time Frame: up to 6 years ]the time from the date of the first cycle of chemotherapy to the progression of disease
- objective response rate [ Time Frame: up to 6 years ]CR, PR and SD rate
- adverse effects [ Time Frame: up to 6 years ]chemotherapy side effects
- quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care [ Time Frame: up to 6 years ]evaluate with FACT-H&N every 3 months after randomiztion
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Firstly diagnosed metastatic nasopharyngeal carcinoma patients
- Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectation at least 12 weeks
- No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
- With at least one measurable lesion
- Enough blood test
- Signed informed consent
Exclusion Criteria:
- Sever heart disease
- HIV infection
- Sever infection
- Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
- Allogeneic organ transplantation
- Malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of Ta,Tis or T1, or any cured cancer for at least 3 years
- Pregnancy or breast feeding
- Difficulty in swallowing
- Received other test drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460419
China, Guangdong | |
SunYat-senU | |
Guangzhou, Guangdong, China, 510060 |
Study Chair: | Xiang Guo, MD | Sun Yat-sen University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | XIANG YANQUN, MD,PhD, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02460419 |
Other Study ID Numbers: |
2015029 |
First Posted: | June 2, 2015 Key Record Dates |
Last Update Posted: | October 28, 2022 |
Last Verified: | October 2022 |
Nasopharyngeal carcinoma metastasis capecitabine |
Carcinoma Nasopharyngeal 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 Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |