TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinica Universidad de Navarra, Universidad de Navarra
About this trial
The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields).
The main questions it aims to answer are:
* Is TTFields treatment safe for the patients in combination with modFOLFIRINOX? * Are participants compliant with the treatment? * Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological/cytological diagnosis of pancreatic adenocarcinoma.
The patient should be 18 years of age and older.
The patient has given consent to participate in the study.
The patient should be able to comply with all the requirements of the clinical trial.
Disqualifiers
Malignancies other than pancreatic cancer within 3 years prior to Cycle 1 Day 1 (C1D1) with the exceptions of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival higher than 90 percentage), treated with expected curative outcome (such as but not limited to: adequately treated in situ carcinoma of the cervix, basal squamous or melanomatous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.
Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to study entry.
Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.
Trial design
Design model
Single group
Treatments tested in this trial
TTFields concomitant with modFOLFIRINOX
Combination productPatients will receive the following medication in 14-day cycles: ModFOLFIRINOX * Folic acid (Leucovorin) 400mg/m2 (D,L, racemic form) or 200mg/m2 (L-isomer form) * 5-fluorouracil (5Fu) 2400 mg/m2 * Oxaliplatin 85mg/m2 * Irinotecan 150-180mg/m2 Combined with TTFields, which is a portable battery operated system intended for continuous home use (at least 18h/day) which delivers TTFields at a frequency of 150kHz to produces electric forces intended to disrupt cancer cell division.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TTFields concomitant with modFOLFIRINOXExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX
Toxicity profile measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0
Time frame
From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) through study completion (for a maximum of 24 months per patient since inclusion)Secondary outcomes
1
Total hours with TTField device functioning during every 14 days chemotherapy cycle
Total account of hours with TTField device functioning during every 14days chemotherapy cycle in the ITT population.
Time frame
From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) until discontinuation of last study treatment (for a maximum of 24 months per patient since inclusion).2
Quality of life (QoL) assessment
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of 30 items (EORTC QLQ-30). Questions 1-28: scale from 1 to 4, where 1 means a better quality of life and 4 indicates a worse quality of life; questions 29-30: scale from 1 to 7, where low scores indicate poorer health and quality of life, while high scores indicate better health and quality of life.
Time frame
Screening visit, from cycle 13 (since completion of treatment with mFOLFIRINOX) onwards at each visit with test according to protocol, and at post-treatment termination visit (for a maximum of 24 months per patient since inclusion).3
Progression-free survival (PFS)
The time in months from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first.
Time frame
Every 8 weeks from the beginning of the first treatment cycle (cycle 1) through study completion (for a maximum of 24 months per patient since inclusion).4
Overall survival (OS)
The time from first modFOLFIRINOX administration until patient death (if it occurs).
Time frame
Since inclusion through study completion (for a maximum of 24 months per patient since inclusion).Sponsors and contacts
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Source ClinicalTrials.gov