Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

NCT ID: NCT00916409

Last Updated: 2017-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-03-31

Brief Summary

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The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. 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

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PAST CLINICAL EXPERIENCE:

The effect of the electric fields generated by the NovoTTF-100A device (TTFields, TTF) has been tested in a large prospective, randomized trial, in recurrent GBM. The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints.

Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy.

In a small scale pilot trial in newly diagnosed GBM patients, the treatment was well tolerated and suggested that NovoTTF-100A may improve time to disease progression and overall survival of newly diagnosed GBM patients. Although the number of patients in the pilot trial was small, The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with newly diagnosed GBM.

DESCRIPTION OF THE TRIAL:

All patients included in this trial are newly diagnosed GBM patients who underwent a biopsy or surgery (with or without Gliadel wafers), followed by radiation therapy in combination with Temozolomide chemotherapy. In addition, all patients must meet all eligibility criteria.

Eligible patients will be randomly assigned to one of two groups:

1. Treatment with the NovoTTF-100A device in combination with Temozolomide chemotherapy.
2. Treatment with Temozolomide alone, as the best known standard of care.

Patients will be randomized at a 2:1 ratio (2 of every three patients who participate in the trial will be treated with the NovoTTF-100A device). Baseline tests will be performed in patients enrolled in both arms, including specific genetic tests done using tumor samples obtained during their initial surgery. If assigned to the NovoTTF-100A in combination with Temozolomide group, the patients will be treated continuously with the device until second progression. They will also receive temozolomide and possibly a second line treatment that can be one of the following: re-operation, local radiotherapy (gamma-knife), a second line of chemotherapy or a combination of the above.

NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. Electrode array placement will require shaving of the scalp before and frequently during the treatment. After an initial short visit to the clinic for training and monitoring, patients will be released to continue treatment at home where they can maintain their regular daily routine.

During the trial, regardless of which treatment group the patient was assigned to, he or she will need to return once every month to the clinic where an examination by a physician and a routine laboratory examinations will be done. These routine visits will continue for as long as the patient's disease is not progressing for the second time under the study treatment. If such occurs, patients will need to return once per month for two more months to the clinic for similar follow up examinations.

During the visits to the clinic patients will be examined physically and neurologically. Additionally, routine blood tests will be performed. A routine MRI of the head will be performed at baseline and every second month thereafter, until second progression. After this follow up plan, patients will be contacted once per month by telephone to answer basic questions about their health status.

SCIENTIFIC BACKGROUND:

Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The breakthrough finding made by NovoCure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields cause these tiny motors to fall apart since they have a special type of electric charge.

As a result of these two effects, cancer tumor growth is slowed and can even reverse after continuous exposure to TTFields.

Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach.

In conclusion, TTField hold the promise of serving as a brand new cancer treatment with very few side effects and promising affectivity in slowing or reversing this disease.

Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NovoTTF-100A device in combination with Temozolomide

patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.

Group Type EXPERIMENTAL

NovoTTF-100A device

Intervention Type DEVICE

patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.

Temozolomide alone, as the best known standard of care

Patients will be treated with Temozolomide, as the best known standard of care for Glioblastoma Multiforme patients.

Group Type ACTIVE_COMPARATOR

Temozolomide

Intervention Type DRUG

maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2-6: At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.

Interventions

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NovoTTF-100A device

patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.

Intervention Type DEVICE

Temozolomide

maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2-6: At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pathological evidence of GBM using WHO classification criteria.
2. \> 18 years of age.
3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):

1. Patients may enroll in the study if received Gliadel wafers before entering the trial
2. Any additional treatments received prior to enrollment will be considered an exclusion.
3. Minimal dose for concomitant radiotherapy is 45 Gy
4. Karnofsky scale ≥ 70
5. Life expectancy at least 3 months
6. Participants of childbearing age must use effective contraception.
7. All patients must sign written informed consent.
8. Treatment start date at least 4 weeks out from surgery.
9. Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.

Exclusion Criteria

1. Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
2. Actively participating in another clinical treatment trial
3. Pregnant
4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:

1. Thrombocytopenia (platelet count \< 100 x 103/μL)
2. Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
4. Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
5. Total bilirubin \> upper limit of normal
6. Significant renal impairment (serum creatinine \> 1.7 mg/dL)
5. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
6. Infra-tentorial tumor
7. Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
8. History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NovoCure Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Stupp, MD

Role: STUDY_DIRECTOR

University Hospital, Zürich

Philip H. Gutin, MD

Role: STUDY_DIRECTOR

Memorial Sloan Kettering Cancer Center

Eric T. Wong, MD

Role: STUDY_DIRECTOR

Beth Israel Deaconess Medical Center

Herbert H. Engelhard, MD, PhD

Role: STUDY_DIRECTOR

University of Illinois at Chicago

Manfred Westphal, Prof. MD

Role: STUDY_DIRECTOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Barrow Neurology Clinics

Phoenix, Arizona, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

University of California San Diego Moores Cancer Center (UCSD)

La Jolla, California, United States

Site Status

University of Southern California (USC)

Los Angeles, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

UF Health Cancer Center at Orlando Health

Orlando, Florida, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

Emory University, Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

University of Illinois at Chicago (UIC)

Chicago, Illinois, United States

Site Status

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Maine Medical Center

Scarborough, Maine, United States

Site Status

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Washington University School of Medicine, Division of Oncology

St Louis, Missouri, United States

Site Status

New Jersey Neuroscience Center - JFK Medical Center

Edison, New Jersey, United States

Site Status

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Mount Sinai Medical Center, Department of Neurosurgery

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Site Status

Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor

Dallas, Texas, United States

Site Status

Methodist Hospital

Houston, Texas, United States

Site Status

Methodist Neurological Institute

Houston, Texas, United States

Site Status

The University of Texas Health Science Center at Houston (UTHSC)

Houston, Texas, United States

Site Status

Scott and White Healthcare

Temple, Texas, United States

Site Status

Memorial Hermann The Woodlands

The Woodlands, Texas, United States

Site Status

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Swedish Neuroscience Institute

Seattle, Washington, United States

Site Status

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University Hospital Graz

Graz, , Austria

Site Status

Medical University of Vienna

Vienna, , Austria

Site Status

SMZ-Süd/Kaiser-Franz-Josef-Spital

Vienna, , Austria

Site Status

Tom Baker Cancer Center

Calgary, Alberta, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status

Notre-Dame Hospital (CHUM)

Montreal, Quebec, Canada

Site Status

Montreal Neurological Institute

Montreal, Quebec, Canada

Site Status

McGill - Gerald Bronfman Centre for Clinical Research in Oncology -

Montreal, Quebec, Canada

Site Status

(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

Sherbrooke, Quebec, Canada

Site Status

Na Homolce Hospital

Prague, , Czechia

Site Status

CHU Amiens Sud-Salouel

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux

Bordeaux, , France

Site Status

Hospital of Neurology Pierre Wertheimer

Lyon, , France

Site Status

Group Hospitals Pitie-Salpetriere

Paris, , France

Site Status

Centre Hospitalo-Universitaire de Toulouse Purpan

Toulouse, , France

Site Status

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Medical University Heidelberg

Heidelberg, , Germany

Site Status

University Hospital of Schleswig-Holstein

Kiel, , Germany

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Az. Ospedaliero-Universitaria - Ospedali Riuniti

Ancona, , Italy

Site Status

Ospedale Lecco

Lecco, , Italy

Site Status

C. Besta Neurological Institute

Milan, , Italy

Site Status

Foundation Hospital Greater Policlinico

Milan, , Italy

Site Status

Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena

Rome, , Italy

Site Status

Asan Medical Center

Asan, , South Korea

Site Status

Yeungnam University Hospital

Daegu, , South Korea

Site Status

Chungnam National University Hospital (CNUH)

Daejeon, , South Korea

Site Status

Samsung Medical Center (SMC)

Seoul, , South Korea

Site Status

Seoul National University Bundang Hospital (SNUBH)

Seoul, , South Korea

Site Status

Seoul National University Hospital (SNUH)

Seoul, , South Korea

Site Status

The Catholic University of Korea, Seoul St. Mary's Hospital (CMC Seoul)

Seoul, , South Korea

Site Status

Yonsei University Severance Hospital (YUHS)

Seoul, , South Korea

Site Status

Ajou University Hospital (AUH)

Suwon, , South Korea

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge-ICO Duran i Reynals

Barcelona, , Spain

Site Status

Fundacion Jimenes Diaz

Madrid, , Spain

Site Status

Hospital 12 de Octubre, Servicio de Oncología Médica

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status

Karolinska Institute

Stockholm, , Sweden

Site Status

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Countries

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United States Austria Canada Czechia France Germany Israel Italy South Korea Spain Sweden Switzerland

References

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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.

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Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

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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.

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Kirson ED, Schneiderman RS, Dbaly V, Tovarys F, Vymazal J, Itzhaki A, Mordechovich D, Gurvich Z, Shmueli E, Goldsher D, Wasserman Y, Palti Y. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). BMC Med Phys. 2009 Jan 8;9:1. doi: 10.1186/1756-6649-9-1.

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Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and Safety of Tumor Treating Fields (TTFields) in Elderly Patients with Newly Diagnosed Glioblastoma: Subgroup Analysis of the Phase 3 EF-14 Clinical Trial. Front Oncol. 2021 Sep 27;11:671972. doi: 10.3389/fonc.2021.671972. eCollection 2021.

Reference Type DERIVED
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Kim CY, Paek SH, Nam DH, Chang JH, Hong YK, Kim JH, Kim OL, Kim SH. Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial. J Neurooncol. 2020 Feb;146(3):399-406. doi: 10.1007/s11060-019-03361-2. Epub 2020 Feb 4.

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Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23.

Reference Type DERIVED
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Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019 Jan;141(2):467-473. doi: 10.1007/s11060-018-03057-z. Epub 2018 Dec 1.

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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.

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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.

Reference Type DERIVED
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Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.

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Meletath SK, Pavlick D, Brennan T, Hamilton R, Chmielecki J, Elvin JA, Palma N, Ross JS, Miller VA, Stephens PJ, Snipes G, Rajaram V, Ali SM, Melguizo-Gavilanes I. Personalized Treatment for a Patient With a BRAF V600E Mutation Using Dabrafenib and a Tumor Treatment Fields Device in a High-Grade Glioma Arising From Ganglioglioma. J Natl Compr Canc Netw. 2016 Nov;14(11):1345-1350. doi: 10.6004/jnccn.2016.0145.

Reference Type DERIVED
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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.

Reference Type DERIVED
PMID: 26670971 (View on PubMed)

Other Identifiers

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EF-14

Identifier Type: -

Identifier Source: org_study_id

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