Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Nivolumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Immunomodulating Agents

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* Neoadjuvant treatment (200 mg/m3 Paclitaxel+ AUC5 Carboplatin+ 360 mg Nivolumab) will start within 1-3 days from randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
* Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3) .
* Adjuvant treatment:Nivolumab: 480 mg Q4W (+/- 3 days) for 6 months (6 cycles). Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week (+ 7 days) from surgery and for 6 months.

* Neoadjuvant treatment (200mg/m3 Paclitaxel+ AUC5 Carboplatin). It will start within 1-3 days from randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
* Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3)

Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.

The infusions must be mixed as soon as possible before the start of each infusion since the stability of paclitaxel beyond 24 hours is not known.

In-line filtration is obligatory since a small number of fibers within the acceptable limits of the USP Particulate Matter Test for LVP have been reported. Cellulose acetate filters of 0.22-micron pore size (such as IVEX II) can be used. The solution that shows excessive particulate matter must be rejected.

Carboplatin must be administered at the end of the Paclitaxel infusion

Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.

The administration of nivolumab infusion must be completed within 24 hours of preparation.

Mariano Provencio, MD

This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial.

90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.

This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial.

Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W. Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days followed by surgery.

The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.

Patient accrual is expected to be completed within 3 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 8.5 years. Patients will be followed 5 years after adjuvant treatment or surgery. The study will end once survival follow-up has concluded.

NADIM II: Neo-Adjuvant Immunotherapy

A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.

The pathological complete response is defined as the absence of residual tumor in lung and lymph nodes in patients treated with chemo-immunotherapy versus patients treated with chemotherapy alone.

Fundación GECP

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Immunologic Factors

Surgery

Chemotherapy, anti-targeted agents and immunotherapy

Radiotherapy

Paula Dr Jiménez Fonseca, MD-PhD

Paula Dr Jimenez Fonseca, MD-PhD

This study aims to development of a database through a web page for epidemiological and clinical research purposes that is accessible to members of the AGAMENON - SEOM group that guarantees a rigorous collection, exploitation and analysis of the data and information contained, increases the knowledge of esophageal and stomach cancer in order to optimize the management, treatment and evolution of patients, the possibility of comparing variables with those of other series or groups, and promotes the quality of scientific publications.

Patient data will be collected from medical records retrospectively.

Spanish Registry of Esophagogastric Cancer

AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer

To evaluate survival (time in months) according to treatment of esophagogastric cancer in all stages, patients, and contexts.

To know the epidemiological profiles of esophagogastric cancer in Spain: temporal and regional trends, morbidity, and mortality.

To study risk factors associated with each subtype of esophagogastric cancer and localization.

To evaluate the pathological features (TNM, grade, histological response)

The TNM is measured with the American Joint Committee on Cancer (AJCC) staging system.

The grade is classified with the WHO scale. Histological response is measured with Becker classification.

To know the diagnostic approch according to the center, type of studies performed: endoscopy, CT, echoendoscopy and/or PET/CT.

From these studies it will be collected whether they have been carried out and where they visualise tumour. The use of scales and measurements is therefore not appropriate.

To compare treatments adjusted to prognostic variables and baseline characteristics.

To validate and compare the three prognostic models for advanced esophagogastric adenocarcinoma: The Royal Marsden Hospital index (Chau et al, 2004), and the models of Kim (2008) and Lee (2007), in a real sample of patients based on daily clinical practice.

To analyze the prognostic factors in this population and build a predictive and/or prognostic model.

To create and validate a predictive model of early mortality.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NADIM II: Neo-Adjuvant Immunotherapy	NCT03838159	Non Small Cell ...	Paclitaxel Carboplatin Nivolumab	18 Years -	Fundación GECP
Spanish Registry of Esophagogastric Cancer	NCT04958720	Esophageal Canc... Gastric Cancer	Surgery Chemotherapy, a... Radiotherapy	18 Years - 100 Years	Fundación Sociedad Española de Oncologia Médica
Spanish Registry of Esophagogastric Cancer	NCT04958720	Esophageal Canc... Gastric Cancer	Surgery Chemotherapy, a... Radiotherapy	18 Years - 100 Years	Fundación Sociedad Española de Oncologia Médica
NADIM II: Neo-Adjuvant Immunotherapy	NCT03838159	Non Small Cell ...	Paclitaxel Carboplatin Nivolumab	18 Years -	Fundación GECP

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