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Gastric CancerNCT04281576

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

A study testing NovoTTF-100L(P), Oxaliplatin and Capecitabine in people with Gastric Cancer and GastroEsophageal Cancer, run by NovoCure Ltd. at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, GastroEsophageal Cancer
What is being tested?
NovoTTF-100L(P), Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteHong Kong
Study dates
19 Dec 2019to 7 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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;
  • HIV positive;
  • Metastases to central nervous system with clinical symptoms. Patients who previously received treatments for the metastases to central nervous system, are stable and meet the following requirements are allowed to be enrolled:
  • No treatment for the metastases to central nervous system during the screening period (e. g. surgery, radiotherapy, corticosteroid therapy-prednisolone > 10 mg/day or equivalent)
  • No progress in central nervous system lesions as indicated by MRI or CT within 14 days prior to the study treatment
  • No meningeal metastasis or spinal cord compression
  • Moderate or severe ascites defined by physical examination and/or CT confirmed
  • Non-healing wound or ulcer within 3 months prior to study enrollment, or history of bone fracture
  • Previous allogeneic organ transplantation or allogeneic bone marrow transplantation
  • Implantable electronic medical devices in the torso.
  • Peripheral neuropathy ≥ Grade 2 (CTCAE 5.0)
  • Except hearing loss, alopecia and fatigue, all toxic reactions caused by previous anti-tumor therapy > Grade 1 (CTCAE 5.0)
  • Other malignant tumors have occurred over the past five years, with the exception of locally curable cancers treated with radical therapy, such as basal or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the cervix, prostate or breast.
  • Subjects who are at increased risk of bleeding or thrombosis:
  • Clinically significant bleeding within 3 months prior to screening or clear bleeding tendency;
  • Gastrointestinal hemorrhage within 3 months prior to screening or clear tendency of gastrointestinal hemorrhage;
  • Arterial/venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, etc.;
  • Require anticoagulation therapy with an agent such as warfarin or heparin;
  • Require chronic anti-platelet therapy (such as aspirin≥100 mg/day, clopidogrel, etc.);
  • History of cardiovascular disease:
  • NYHA (New York Heart Association) grade 3 and 4 congestive heart failure;
  • Unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to screening;
  • Arrhythmias requiring medications other than β-blockers;
  • Patients with valvular heart disease of ≥ CTCAE grade 2;
  • Hypertension inadequately controlled by drugs (systolic pressure >150 mmHg or diastolic pressure >90 mmHg);
  • The investigator considers that there may be an increased risk related to the study or study treatment, or any serious or uncontrolled systemic diseases, such as infection, diabetes, hypertension, that affect the patient's ability to receive the study treatment.
  • Treatment with systemic anticancer agents (including but not limited to chemotherapy, targeted therapy, onco-immunotherapy, and biotherapy (tumor vaccines, cytokines, or cancer related growth factors)) 14 days before the study treatment, or traditional Chinese herbal medicine or Chinese patent medicine for anti-tumor therapy 7 days prior to the treatment.
  • Patients with active chronic hepatitis B or hepatitis C, or co-infection of both, patients with hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive during screening who have hepatitis B virus (HBV) DNA titer > 500 IU/ mL and HCV RNA detectable can be enrolled after active hepatitis B or hepatitis C infection that requires treatment have been ruled out. During the study treatment, corresponding anti-viral treatment should be given.
  • Known history of allergies or hypersensitivities to medical adhesives, hydrogel, standard drugs used in this study or their components.
  • Known history of alcohol or drug abuse.
  • Females who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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

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.

Read the 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.

Being tested
NovoTTF-100L(P), Oxaliplatin, Capecitabine, Trastuzumab
Keywords
TTFields, XELOX, Oxaliplatin, Capecitabine, Minimal toxicity, TTF, Tumor Treating Fields, Novocure, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTF-100L(P)Device

    Also called TTFields

    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.

  • OxaliplatinDrug

    Also called Eloxatin

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

  • CapecitabineDrug

    Also called Xeloda

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

  • TrastuzumabDrug

    Also called Herceptin

    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.

Study groups in NCT04281576
Study groupRoleWhat they receive
NovoTTF-100L(P)ExperimentalPatients receive TTFields using the NovoTTF-100L(P) System together with XELOX. For HER-2 positive patients, Trastuzumab is given together with XELOX.
Receives: Device: NovoTTF-100L(P); Drug: Oxaliplatin; Drug: Capecitabine; Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

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

    Measured: 2 years

Secondary outcomes (7)

  1. Progression-free survival

    Measured: 2 years

  2. Overall survival

    Measured: 2 years

  3. Disease control rate

    Measured: 2 years

  4. Time to progression

    Measured: 2 years

  5. Duration of response

    Measured: 2 years

  6. 12 month overall survival rate

    Measured: 2 years

  7. Severity and frequency of adverse events

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start19 Dec 2019
  3. Primary completion7 Jun 2024
  4. Study completion7 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281576
Sponsor's protocol ID
EF-31 / ZL-8301-001
Status last verified
Nov 2024
First submitted
20 Feb 2020
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15126372

  • 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.

    PubMed 17551011

  • 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.

    PubMed 22608262

  • 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.

    PubMed 19387848

  • 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.

    PubMed 26658786

  • 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.

    PubMed 26670971

  • 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.

    PubMed 29260225

  • 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.

    PubMed 29392280

Questions about this trial

What is this clinical trial studying?

A study testing NovoTTF-100L(P), Oxaliplatin and Capecitabine in people with Gastric Cancer and GastroEsophageal Cancer, run by NovoCure Ltd. at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281576, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.

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Clinical Trial NCT04281576 | AzTrials