UnknownPhase 2

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

China45 participantsStarted 2017-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. sign written informed consent form
. age ≥ 18 years
. pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67\>20%);
. 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;
. 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);
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall response rate (ORR)

Timeframe: 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

Trial details

NCT IDNCT03279614

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-01

View on ClinicalTrials.gov More Neuroendocrine Carcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. sign written informed consent form
. age ≥ 18 years
. pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67\>20%);
. 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;
. 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);
. 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;

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria