NCT04281576

Effect of Tumor Treating Fields (TTFields, 150 KHz) Concomitant with Chemotherapy As First Line Treatment of Unresectable Gastroesophageal Junction or Gastric Adenocarcinoma

A Phase 2, Single Arm, Multi-center, Open-Label Trial to Evaluate the Safety and Efficacy of Treatment with Tumor Treating Fields (TTFields) and Chemotherapy As First-Line Treatment for Subjects with Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Gastric (GC) Adenocarcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: NovoCure Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, single arm, phase II trial aimed to evaluate the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with XELOX for the treatment of unresectable, locally advanced or metastatic Gastroesophageal Junction (GEJ) or Gastric (GC) Adenocarcinoma who were previously untreated with systemic therapy. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Detailed description

PAST PRE-CLINICAL AND CLINICAL EXPERIENCE: The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro gastric cancer pre-clinical models both as a single modality treatment and in combination with chemotherapies. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment. Prospective, multi-center clinical studies of TTFields have shown the safety of the treatment when administered to the abdomen for pancreatic cancer and ovarian cancer. In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life. DESCRIPTION OF THE TRIAL: All patients included in this trial are patients with unresectable Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. In addition, all patients must meet all eligibility criteria. All eligible patients will receive continuous Tumor Treating Fields (TTFields) - NovoTTF-100L (P) treatment at 150 KHz frequency, and XELOX regimen (combination of oxaliplatin + capecitabine). Patients will be assessed once every 9 weeks according to RECIST v1.1. Study treatment should be continued until disease progression, intolerable toxicity or withdrawal of informed consent.

Conditions

• Gastric Cancer
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DEVICE	NovoTTF-100L(P)	Patients receive continuous TTFields treatment using the NovoTTF-100L(P) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. The treatment enables the patient to maintain regular daily routine.
DRUG	Oxaliplatin	Oxaliplatin 130 mg/m\^2 intravenous infusion will be administered once every 3 weeks
DRUG	Capecitabine	Capecitabine 1000mg/m\^2 taken by mouth, twice daily on day 1-14, 3 weeks per cycle
DRUG	Trastuzumab	Trastuzumab (HER-2 positive patients only) intravenous infusion will be administered once every 3 weeks on Day 1 of each cycle. First dose is 8mg/kg, followed by 6 mg/kg.

Timeline

• Start date: 2019-12-19
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2020-02-24
• Last updated: 2024-11-14

Locations

1 site across 1 country: Hong Kong