CLINICAL TRIAL

All patients- TAS-102 for Carcinoma, Neuroendocrine

Metastatic
Refractory
Recruiting · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a drug may be effective in treating high-grade neuroendocrine cancer.

See full description

About the trial for Carcinoma, Neuroendocrine

Eligible Conditions
Carcinoma, Neuroendocrine · High-grade Extra Pulmonary Neuroendocrine Cancer

Treatment Groups

This trial involves 2 different treatments. All Patients- TAS-102 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
All patients- TAS-102
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Pathologic confirmation of high grade NEC using WHO criteria as determined by Ki67>20%, poorly differentiated (G3) characteristics, or >20 mitotic figures/10 high-power fields.
Unknown primary may be included. Suspected extrapulmonary patients with known lung primary will be excluded.
Prior treatment with a platinum containing regimen
RECIST 1.1 measurable disease
Evidence of stage IV, metastatic disease
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Serum albumin ≥2.5 gm/dL.
Expected survival ≥3 months.
Adequate hematologic function as defined by: a) Absolute neutrophil count (ANC) >1500/mm3; b) Platelets ≥75,000/mm3; c) Hemoglobin >8 g/dL (in the absence of red blood transfusion).
Adequate liver function, as defined by: a) Serum total bilirubin ≤2.5 x ULN mg/dL. b) ALT (SGPT) and AST (SGOT) ≤5 x upper limit of normal (ULN).
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether All patients- TAS-102 will improve 1 primary outcome and 2 secondary outcomes in patients with Carcinoma, Neuroendocrine. Measurement will happen over the course of 24 months.

Overall Survival (OS)
24 MONTHS
To assess OS in patients with metastatic extra pulmonary high grade NEC who received TAS-102 In comparison with historical records.
24 MONTHS
Progression free survival (PFS)
24 MONTHS
To assess PFS in patients with metastatic extra pulmonary high grade NEC who received TAS-102 in comparison with historical records
24 MONTHS
Overall Response Rate (ORR)
24 MONTHS
To assess clinical activity [ORR = Partial response (PR)+Complete response (CR) ] of TAS-102 in patients with metastatic, extra pulmonary high grade NEC
24 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes carcinoma, neuroendocrine?

There may be multiple causes of the carcinoma, neuroendocrine type. There is no doubt that it is mainly due to exposure to certain hormones and chemicals. And hormonal agents may also influence the risk of carcinoma, neuroendocrine type by altering the body's metabolic activity.

Anonymous Patient Answer

How many people get carcinoma, neuroendocrine a year in the United States?

The average U.S. population in 1995-96 had 47,000 new diagnosis cases of carcinoma (13,000 women), and 34,000 new diagnosis cases were neuroendocrine (9,000 women). The number of new diagnosis cases with carcinoma increased for all ages, regardless of sex.

Anonymous Patient Answer

What are the signs of carcinoma, neuroendocrine?

Signs include weight loss, loss of appetite, malaise, fatigue, blood-stained urine, and a firm enlargement of the cervical lymph nodes that are usually on the left under the arm. Also found are the symptoms of neuroendocrine cancer: Cushing's syndrome, and thyroid dysfunction.

Anonymous Patient Answer

What is carcinoma, neuroendocrine?

There are various forms of carcinoma with different mechanisms of formation. In most cases, carcinomas formed are benign tumors or malignant tumors in early stage. Carcinoma, neuroendocrine tumors is a tumor formed or made by cells of endocrine apparatus, it is thought to originate from embryonic remnants (brain or other organs) or endocrine malfunction.\n

Anonymous Patient Answer

What are common treatments for carcinoma, neuroendocrine?

Radiation therapy is the sole treatment commonly used for carcinoma of neuroendocrine origin, but it is not always helpful. Other treatments commonly used are chemotherapy or combined therapies. Survival depends on the exact type of thyroid cancer and the staging of the disorder.\n

Anonymous Patient Answer

Can carcinoma, neuroendocrine be cured?

The most conclusive result was achieved in a curative group with limited disease. However, the cure rate was less than 50% in this group, and treatment failures occurred in most patients. Although some patients with advanced PNETs received curative resection, the overall good response rate suggests that a cure is achievable in some patients. Because patients with limited disease achieved a cure rate of 50%, the treatment approach should be changed to focus on this group of patients.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, neuroendocrine?

Clinical trials are the best opportunity for patients with neuroendocrine cell cancers for treatment innovation, but clinical eligibility criteria are ambiguous and are poorly implemented by clinical oncologists.

Anonymous Patient Answer

What does all patients- tas-102 usually treat?

No reliable information is yet available on the efficacy of Tas-102-treated patients. Based on the experience with Tas-102 of different European and American centers, the clinical management plan of Tas-102, that we present, should help clinicians to make rational treatment decisions in most of the patients with Tas-102 treated carcinoid or neuroendocrine tumors.

Anonymous Patient Answer

What are the common side effects of all patients- tas-102?

Based on our clinical survey, we recommend that all patients receive the tas-102 infusion with a gradual increase in dose; at first, the patients receive two doses every three weeks, and then, in one week, they are transferred from two to six doses every three weeks. In general, patients experienced no symptoms, and the therapeutic effect was acceptable. After some patients complained of adverse reactions, we found that the patients who had been taking tas-102 more often exhibited higher BCLT scores when they stopped their treatments. We believe that the BCLT should be monitored continuously when tas-102 is given to patients, especially those who had been taking tas-102 at a high dose.

Anonymous Patient Answer

Does carcinoma, neuroendocrine run in families?

It was concluded that carcinoma, neuroendocrine families appear to have a different phenotype than noncarinoma, neuroendocrine families, but this difference was not reflected in an increased rate of family members with multiple neoplasms.

Anonymous Patient Answer

Is all patients- tas-102 safe for people?

All patients in this trial showed excellent safety. Adverse events were experienced by several in the control group, all of which were Grade 1 or 2, and none of these patients had serious adverse events. There were four patients in the tas-102 group who required no further interventions, and all had Grade 1 adverse events. There were 20 patients in the tas-102 group who required treatment, and 14 had a serious adverse event. None of these events was fatal or required interventional treatment. There were no unexpected serious adverse events experienced. [Patient-tas-102 is not medically dangerous]. This trial has proven patients' safety.

Anonymous Patient Answer

Have there been other clinical trials involving all patients- tas-102?

It is not known if there have been other trials which use all patient populations and the results from these other studies have been applied to the design of NEPE. We have used the study sample size and result from our tas-102 study to predict if we would detect this effect from our current study design. We believe that the study is under powered and more work is required to investigate the exact effect size for the design we used.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Neuroendocrine by sharing your contact details with the study coordinator.