Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Neuroendocrine Tumor | Drug: Etoposide Drug: Irinotecan | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Etoposide Plus Cisplatin Compared With Irinotecan Plus Cisplatin for First-line Treatment of Non-primary Pancreatic Metastatic and/or Unresectable Gastrointestinal Neuroendocrine Tumor G3 Type |
Estimated Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 1, 2020 |
Estimated Study Completion Date : | June 1, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Etoposide plus Cisplatin
Etoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over.
|
Drug: Etoposide
Etoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days.
Other Name: Cisplatin
|
Experimental: Irinotecan plus Cisplatin
Irinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over.
|
Drug: Irinotecan
Irinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days.
Other Name: Cisplatin
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. 18-75 years old, male or female. 2. Confirmed non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type patients by histopathological and imaging examinations.
3. ECOG performance status 0-1. 4. Life expectancy ≥ 12 weeks. 5. A histological specimen can be provided for secondary testing. 6. According to the evaluation criteria of solid tumor efficacy (RESIST 1.1), there should be at least one measurable lesion (empty organs such as esophagus and stomach cannot be taken as the measurable lesion), and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area is also selected as the target lesion if the lesion progression is confirmed).
7. Never received system treatment before, including cytotoxic drugs. For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs can be screened.
8. The main organ function meets the following criteria within 7 days before treatment:
9. Fertile men and women must use effective contraception during the study period and within 6 months after the end of the study.
10. Volunteered to participate in the study and signed an informed consent form.
Exclusion Criteria:
1.Patients exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in site, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor infiltrating basement membrane)); Patients with rapid progress within 3 months.
2. History of gastrointestinal perforation and/or fistula within 6 months prior to the first administration.
3. Patients who had received radiotherapy for tumor target lesions within 4 weeks before enrollment.
4. History of immunodeficiency disease, including HIV positive and other acquired or congenital immunodeficiency diseases.
5. Allergic reactions and drug adverse reactions:
6. Significantly malnourished patients. Exclusion is performed if the patient is receiving intravenous fluids or is required to be hospitalized for continuous infusion therapy. Patients with good nutrition control ≥ 28 days can be enrolled before randomization.
7. Any severe and/or uncontrolled disease, including:
9. Patients who underwent surgical treatment, incision biopsy or significant traumatic injury within 28 days prior to enrollment.
10. Any bleeding event ≥ CTC AE grade 3 or unhealed wounds, ulcers or fractures in 4 weeks prior to enrollment.
11. Arterial/venous thrombosis events within 3 months, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis and pulmonary embolism.
12. Patients who prepared or accepted previously allogeneic organ or bone marrow transplantation, including liver transplantation.
13. Concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study according to the investigator's judgment.
14. Patients cannot provide histological specimens for secondary test. 15. Patients who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder.
16. Urine routine showed urinary protein ≥ 2 + and 24-hour urine protein quantitation > 1.0 g.
17. Patients with brain metastases. 18. Patients who have participated in other anti-tumor drug clinical trials within 4 weeks.
Contact: Ying Liu | 13783604602 | yaya7207@126.com |
Study Director: | Baoxia He | Henan Cancer Hospital |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | May 20, 2019 | ||||
First Posted Date ICMJE | May 24, 2019 | ||||
Last Update Posted Date | May 24, 2019 | ||||
Estimated Study Start Date ICMJE | June 1, 2019 | ||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Etoposide/Cisplatin Compared With Irinotecan/Cisplatin for Advanced Gastrointestinal Neuroendocrine Tumor G3 Type | ||||
Official Title ICMJE | Phase II Trial of Etoposide Plus Cisplatin Compared With Irinotecan Plus Cisplatin for First-line Treatment of Non-primary Pancreatic Metastatic and/or Unresectable Gastrointestinal Neuroendocrine Tumor G3 Type | ||||
Brief Summary | The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy. | ||||
Detailed Description | The prognosis of gastrointestinal neuroendocrine tumor G3 type patients who cannot be surgically resected is poor. The median overall survival (OS) is only 6-10 months, and the 3-year survival rate is less than 10%. Among the neuroendocrine tumors of the digestive system, only pancreatic neuroendocrine tumor has a standard treatment strategy, and there is a lack of prospective clinical research data on other gastrointestinal neuroendocrine tumors. According to the chemotherapy regimen of small cell lung cancer, etoposide plus cisplatin or irinotecan plus cisplatin is the choice of rescue therapy for advanced non-surgical or metastatic neuroendocrine tumor G3 type. However, prospective studies are needed to confirm whether there are differences in efficacy and safety between the two chemotherapy regimens. The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Gastrointestinal Neuroendocrine Tumor | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
112 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2021 | ||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03963193 | ||||
Other Study ID Numbers ICMJE | HNCH-GI-005 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Henan Cancer Hospital | ||||
Study Sponsor ICMJE | Henan Cancer Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Henan Cancer Hospital | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |