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Report for Clinical Trial NCT03764553

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Liposomal iRInotecan, Carboplatin or oXaliplatin in the First Line Treatment of Esophagogastric Cancer: a Randomized Phase 2 Study

This is a multi-center, open label, randomized phase II trial for patients with previously untreated metastatic or locally advanced esophagogastric cancer, using a pick the winner design to identify the best combination therapy in terms of progression free survival and neurotoxicity.

NCT03764553 Esophageal Cancer

6 Interventions

Name: Liposomal Irinotecan

Description: Iv liposomal irinotecan
Type: Drug
Group Labels: 1

Liposomal irinotecan, leucovorin and 5FU

Name: Carboplatin

Description: IV Carboplatin
Type: Drug
Group Labels: 1

Carboplatin and capecitabine

Name: Capecitabine

Description: PO Capecitabine
Type: Drug
Group Labels: 2

Carboplatin and capecitabine oxaliplatin and capecitabine

Name: Oxaliplatin

Description: IV Oxaliplatin
Type: Drug
Group Labels: 1

oxaliplatin and capecitabine

Name: 5-fluorouracil

Description: IV 5-fluorouracil
Type: Drug
Group Labels: 1

Liposomal irinotecan, leucovorin and 5FU

Name: Leucovorin

Description: IV Leucovorin
Type: Drug
Group Labels: 1

Liposomal irinotecan, leucovorin and 5FU


Primary Outcomes

Description: To compare the progression free survival

Measure: Progression free survival

Time: 42 months

Description: Number of participants with treatment-related Neurotoxicity according to CTCAE v4.0

Measure: Number of participants with treatment-related Neurotoxicity

Time: 42 months

Secondary Outcomes

Description: To determine the overall survival of F-Nal-IRI, capecitabine/Carboplatin (CapCar) and capecitabine/oxaliplatin (CapOx)

Measure: Overall survival

Time: 54 months

Description: To determine the response rate of F-Nal-IRI, CapCar and CapOx

Measure: response rate

Time: 42 months

Description: To determine the adverse events of F-Nal-IRI, CapCar and CapOx according to NCI common toxicity criteria (CTC) version 4

Measure: adverse events

Time: 42 months

Description: Overall Quality of life ranging from 0-100 with 100 being best Quality of Life

Measure: Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ C30))

Time: 42 months

Description: The percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of treatment.

Measure: percentage subsequent treatment lines

Time: 42 months

Description: Reasons for forgoing subsequent treatment after progression on first-line treatment

Measure: the reasons for forgoing subsequent treatment

Time: 42 months

Other Outcomes

Description: Percentage of stroma and tumor immune infiltrate in metastatic tumor tissue as predictor of response to treatment and survival.

Measure: Tumor micro environment

Time: 54 months

Description: Concentration of ADAM12 in blood

Measure: Stromal markers in blood

Time: 54 months

Description: Growth velocity of tumor organoids after treatment measured in days

Measure: Growth velocity of patient derived tumor organoids

Time: 54 months

Description: Concentration circulating tumour DNA (ctDNA) as a marker of response to treatment

Measure: ctDNA

Time: 54 months

Description: Composition of the fecal microbiome as a potential biomarker for response to treatment and toxicity

Measure: Fecal microbiome

Time: 54 months

Description: The cost effectiveness in terms of QUALYs associated with treatment of F-Nal-IRI, CapCar and CapOx

Measure: Costs associated with treatment of F-Nal-IRI, CapCar and CapOx

Time: 54 months

Description: Expression of ADAM12 in metastatic tumor tissue

Measure: Stromal Markers in tumor

Time: 54 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 P4503A

- Current use or any use in last two weeks of strong cytochrome P4503A (CYP3A-enzyme), CYP2C8, and/or strong UDP glucuronosyltransferase (UGT1A) inhibitors/inhibitors - Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of study treatment. --- P4503A ---



HPO Nodes