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The study will be conducted to compare the safety and efficacy of Capecitabine Combined With Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Capecitabine Combined With Dacarbazine(CAPDTIC) | Experimental | patients in arm A will receive chemotherapy of CAPDTIC regimen: Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W, Dacarbazine: 200mg/m2 ,iv drip,d1-5 q4W |
|
| B: Capecitabine Combined Temozolomide(CAPTEM) | Experimental | patients in arm B will receive chemotherapy of CAPDTEM regimen: Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ,p.o.d10-14 q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine, Dacarbazine | Drug | Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ,iv drip,d1-5 q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause | baseline, every 8 weeks up to 1 year after last patient first treatment |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen | Contact | 86-10-88196561 | linshenpku@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Capecitabine, Temozolomide | Drug | Capecitabine: 1000mg/m2 ,p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ,p.o. bid d10-14 q4W, |
|
Overall survival is defined as the time from date of start of treatment to date of death due to any cause |
| baseline, every 8 weeks up to 1 year after last patient first treatment |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D003606 | Dacarbazine |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
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