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Study to Evaluate the Efficiency of SOX as Seconde-line Chemotherapy in Neuroendocrine Carcinoma

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ClinicalTrials.gov Identifier: NCT03279614
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief Summary:
Currently, there is no standard second line treatment for patients with neuroendocrine carcinoma. SOX regimen has shown promising in previous study. The study was designed to confirm thet SOX regimen can be used as a second-line regimen for patients with advanced or metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with platinum based regimen.

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma Drug: SOX Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of SOX as the Seconde Line Chemotherapy in Advanced or Metastatic Neuroendocrine Carcinoma
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SOX
OXA:130mg/m2 ,iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W
Drug: SOX
OXA:130mg/m2 ,iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 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 ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation by RECIST 1.1


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment ]
    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

  2. Overall survival [ Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment ]
    Overall survival is defined as the time from date of start of treatment to date of death due to any cause

  3. Incidence of Treatment-related Adverse Events (Safety and Tolerability) [ Time Frame: 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 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. sign written informed consent form
  2. age ≥ 18 years
  3. pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67>20%);
  4. No prior antitumor treatment with OXA, progress after first line chemotherapy with platinum-based regimen. For recurrent patients after radical surgery, platinum-based adjuvant chemotherapy should beyond 6 months prior to randomization;
  5. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
  6. Screening laboratory values must meet the following criteria (within past 7 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
  7. KPS ≥ 70;
  8. Predicted survival >=3 months;
  9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
  10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

  1. Hypersensitivity to OXA,5-HT3 receptor antagonists;
  2. Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
  3. Received surgery within past 4 weeks, or have not recovered from surgery;
  4. Severe diarrhea;
  5. Concurrent severe infection;
  6. Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  7. Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment);
  8. Meningeal carcinomatosis;
  9. Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease;
  10. Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency;
  11. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
  12. History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;
  13. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons;
  14. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

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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): NCT03279614


Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Lin Shen    86-10-88196561    linshenpku@163.com   
Sponsors and Collaborators
Peking University

Responsible Party: Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT03279614     History of Changes
Other Study ID Numbers: SOX-2
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shen Lin, Peking University:
ORR
OS
PFS
safety

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue