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

NCT04281576 | Completed

• 1 other identifier: EF-31 / ZL-8301-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; GastroEsophageal Cancer

Keywords

TTFields; XELOX; Oxaliplatin; Capecitabine; Minimal toxicity; TTF; Tumor Treating Fields; Novocure; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Investigator-assessed objective response rate (ORR) as per RECIST v1.1

  2 years

Secondary Outcomes (7)

• Progression-free survival

  2 years

• Overall survival

  2 years

• Disease control rate

  2 years

• Time to progression

  2 years

• Duration of response

  2 years

Study Arms (1)

NovoTTF-100L(P)

EXPERIMENTAL

Patients receive TTFields using the NovoTTF-100L(P) System together with XELOX. For HER-2 positive patients, Trastuzumab is given together with XELOX.

Device: NovoTTF-100L(P); Drug: Oxaliplatin; Drug: Capecitabine; Drug: Trastuzumab

Interventions

NovoTTF-100L(P) DEVICE

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.

Also known as: TTFields

NovoTTF-100L(P)

Oxaliplatin DRUG

Oxaliplatin 130 mg/m\^2 intravenous infusion will be administered once every 3 weeks

Also known as: Eloxatin

NovoTTF-100L(P)

Capecitabine DRUG

Capecitabine 1000mg/m\^2 taken by mouth, twice daily on day 1-14, 3 weeks per cycle

Also known as: Xeloda

NovoTTF-100L(P)

Trastuzumab DRUG

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.

Also known as: Herceptin

NovoTTF-100L(P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to and be able to sign an informed consent form
• Male or female aged ≥ 18 years
• Be able to receive the treatment in compliance with the study protocol in the discretion of the investigator
• ECOG Performance status score 0 or 1
• Histologically confirmed unresectable, locally advanced or metastatic Gastroesophageal Junction (GEJ) or Gastric (GC) Adenocarcinoma. The subject must be previously untreated with systemic treatment (including chemotherapy, targeted therapy, and Onco-Immunotherapy), and without resection of primary gastric focus.
• Subjects must have at least one measurable lesion as per RECIST 1.1 criteria; and the tumor assessment baseline should be performed and established by the investigator within 28 days prior to study treatment.
• Life expectancy ≥ 3 months
• The allowed previous treatment: Palliative radiotherapy for bone metastasis is allowed if it has been completed within 2 weeks prior to the study treatment and all treatment-related toxicity should be recovered to Grade 1 before enrollment, according to CTCAE 5.0.
• Women of childbearing potential must have a negative serum pregnancy test result during screening. Post-menopausal women and surgically sterilized women are not required to undergo a pregnancy test. Females of childbearing potential/males and its partners who are sexually active must agree to adopt methods of contraception from signing the ICFs to within at least 6 months after the last dose of study drug. Besides, male subjects must be willing to refrain from sperm donation during this time.
• Able to operate the NovoTTF-100L (P) System independently or with the help of a caregiver.

You may not qualify if:

• White blood cell count (WBC) \< 2 × 10\^9 / L
• Absolute neutrophil count (ANC) \< 1.5 × 10\^9 / L
• Platelet count \< 100 × 10\^9 / L
• Hemoglobin \< 90 g/L
• Serum albumin \< 30 g/L
• Serum creatinine \> 1.5 × ULN, or creatinine clearance\< 60 mL/min/1.73 m\^2 calculated by Cockcroft-Gault
• Serum total bilirubin \> 1.5 × ULN
• AST, ALT, ALP:
• Patients without liver metastasis or bone metastases i. AST or ALT \>1.5 × ULN and ALP \> 2.5 × ULN ii. AST or ALT \>2.5 × ULN
• Patients with liver metastasis and without bone metastases i. AST or ALT \> 5 × ULN and ALP \> 2.5 × ULN
• Patients with liver metastasis and bone metastases i. AST or ALT \> 5 × ULN and ALP \> 10 × ULN
• Patients without liver metastasis and with bone metastases i. AST or ALT \> 1.5 × ULN and ALP \> 10 × ULN
• Coagulation function: International Normalized Ratio (INR) \> 2.3 or Prothrombin Time (PT) of \> 6 seconds above the reference.
• The other abnormal laboratory test:
• Electrolyte disorder including hyponatremia, hypokalemia and hypophosphatemia before the first dose, which cannot be restored by fluid and electrolyte therapies;

Sponsors & Collaborators

• NovoCure Ltd.: lead
• Zai Lab (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (8)

• Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

  PMID: 15126372 BACKGROUND

• Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

  PMID: 17551011 BACKGROUND

• Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

  PMID: 22608262 BACKGROUND

• Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

  PMID: 19387848 BACKGROUND

• Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

  PMID: 26658786 BACKGROUND

• Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

  PMID: 26670971 BACKGROUND

• Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.

  PMID: 29260225 BACKGROUND

• Taphoorn MJB, Dirven L, Kanner AA, Lavy-Shahaf G, Weinberg U, Taillibert S, Toms SA, Honnorat J, Chen TC, Sroubek J, David C, Idbaih A, Easaw JC, Kim CY, Bruna J, Hottinger AF, Kew Y, Roth P, Desai R, Villano JL, Kirson ED, Ram Z, Stupp R. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):495-504. doi: 10.1001/jamaoncol.2017.5082.

  PMID: 29392280 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: December 19, 2019
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

HK (1)