Real world retrospective study of therapies in lung and thymic carcinoids - A study of the ENETS Lung Task Force

Level: Level 3

Launch date: 1 September 2023

Principle investigators: Thomas WALTER & Anna KOUMARIANOU

Project description:

Background and aims:

This study is organised by the ENETs Lung Task Force and aims to retrospectively collect real-world data on the clinical efficacy and the antineoplastic effect of somatostatin analogues (SSA) and peptide receptor radionuclide therapy (PRRT) in typical and atypical advanced/metastatic neuroendocrine tumours (NETs).

All data will be collected from ENETs multidisciplinary centers and centers specialised in the field, to guarantee quality data.

The primary endpoint of this study is to assess the progression free survival (PFS) of patients with advanced lung and thymic NETs treated with SSA and PRRT.

The secondary objectives of this study are to assess:

·        the dose and duration of treatment

·        the clinical efficacy (symptomatic response)

·         the toxicity of SSA and PRRT

·        the objective response rate

·        the disease control rate

·        the PFS at 12 months

·        overall survival.

Other treatment parameters will be analysed such as presence of a functioning syndrome, sequence of treatments, effectiveness of rechallenge with the same treatment, occurrence and reasons of dose modifications.

The dataset has also the function to record current clinical practices around collaborative ENETs groups, and to disseminate the results in the form of abstracts and publications.

Inclusion criteria:

All patients with typical or atypical thoracic (lung and thymus) carcinoid tumours (NETs), treated by either SSA and/or PRRT.

Methods: The two studies will be described separately in two papers. However, one patient who received SSA and PRRT will be therefore included in both studies.

Publication rules: Every participating institution will have 1 (co)-authorship, further participating persons of the same institution will be listed in the acknowledgements. If the number of co-authors has to be limited to a journals policy, the order will be determined according to the patient numbers recruited.

The first author is the chairperson or PI of the study group of the study (designer/methodologist of the study).

The second author is the best recruiter in terms of numbers and quality or the co-main author (if not the PI of the study).

Subsequent author hierarchy is dependent on quality/quantity of recruitment/methodologist.

The last author is the second chairperson/PI of the study (if among best recruiter).