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Gene-Guided therapy may outperform chemo for mysterious cancers

NCT ID NCT03498521

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using a person's tumor genetic profile to choose treatment works better than standard chemotherapy for cancer of unknown primary (CUP). About 529 adults whose cancer was controlled after initial chemo were randomly assigned to either gene-guided therapy or more chemo. The goal was to see which approach delays cancer growth longer. Results could help tailor treatment for this hard-to-treat cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

529 people

The number who actually took part.

Started

Jul 2018

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed according to criteria defined in the 2015 European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for CUP * No prior lines of systemic therapy for the treatment of CUP * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Candidate for platinum-based chemotherapy (according to the reference information for the intended chemotherapy) * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) * Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample \</= 4 months old that is expected to be sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory Exclusion Criteria: * Squamous cell CUP * Participants who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor (favorable prognosis CUP subsets): Poorly differentiated carcinoma with midline distribution; women with papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes; poorly differentiated neuroendocrine tumors; men with blastic bone metastases and elevated prostate-specific antigen (PSA); participants with a single, small, potentially resectable tumor; colon cancer-type CUP, including participants with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile; CK7-positive, CK20-negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma or thyroid cancer; IHC profile definitely indicative of breast cancer OR an IHC profile indicative of breast cancer and either a history of breast cancer or lymph nodes in the drainage areas of the breast; high-grade serious carcinoma histology and elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass or lymph node in the abdominal cavity; IHC profile suggestive of renal cell carcinoma and renal lesions, with a Bosniak classification higher than IIF; IHC profile compatible with cholangiocarcinoma or pancreatobiliary (or upper gastrointestinal carcinoma) AND 1 or 2 liver lesions without extrahepatic disease or with only pulmonary metastases and/or lymph nodes in the drainage areas of the liver * Known presence of brain or spinal cord metastasis (including metastases that have been irradiated only) * Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma * History or known presence of leptomeningeal disease * Known human immunodeficiency virus (HIV) infection * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 7 months after the final dose of treatment

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Conditions

The condition(s) this trial relates to.

cancer of unknown primary site Neoplasms, Unknown Primary

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer of unknown primary site

Contacts and locations

Locations

  • ?zmir Medical Point

    Kar?iyaka, 35575, Turkey (Türkiye)

  • AVIX Investigación Clínica S.C

    Monterrey, Nuevo León, 64710, Mexico

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Aichi Cancer Center

    Aichi, 464-8681, Japan

  • Akdeniz University Medical Faculty

    Antalya, 07070, Turkey (Türkiye)

  • Akershus universitetssykehus HF

    Lørenskog, 1478, Norway

  • Ankara Oncology Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Ankara University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Anticancer Hospital Ag Savas

    Athens, 115 22, Greece

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24128, Italy

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    Milan, Lombardy, 20162, Italy

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01250, Turkey (Türkiye)

  • Blacktown Hospital

    Blacktown, New South Wales, NSW 2148, Australia

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383, Chile

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145, Hungary

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000, Hungary

  • CHRU Besançon

    Besançon, 25030, France

  • CHU Lyon - Centre Hospitalier Lyon Sud

    Pierre-Benite (Lyon), 69495, France

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, 67098, France

  • CRLCC-Francois Baclesse

    Caen, 14076, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

    Clermont-Ferrand, 63003, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347, Romania

  • Chaim Sheba medical center, Oncology division

    Ramat Gan, 5262000, Israel

  • Charité-Universitätsm. Berlin

    Berlin, 13353, Germany

  • Christie Hospital NHS Trust

    Manchester, M20 4BX, United Kingdom

  • Clinica del Country

    Bogotá, 11001, Colombia

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700, Thailand

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice

    Prague, 128 08, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065, Australia

  • Hacettepe Uni Medical Faculty Hospital

    S?hhiye, Ankara, 06100, Turkey (Türkiye)

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Health Pharma Professional Research

    CD Mexico, Mexico CITY (federal District), 03810, Mexico

  • Helsinki University Central Hospital

    Helsinki, 00250, Finland

  • Hopital Foch

    Suresnes, 92151, France

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Sant Joan Despi- Moises Broggi

    Sant Joan Despí, Barcelona, 08970, Spain

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • IASO General Hospital of Athens

    Athens, 155 62, Greece

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

  • Ico - Paul Papin

    Angers, 49000, France

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101, Australia

  • Inst. Nacional de Cancerologia

    Bogotá, Colombia

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Institut Curie

    Paris, 75231, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Institut régional du Cancer Montpellier

    Montpellier, 34298, France

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120, Brazil

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038, Peru

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131, Italy

  • James Lind Centro de Investigación Del Cáncer

    Temuco, 4800827, Chile

  • Klinikum Mannheim III. Medizinische Klinik

    Mannheim, 68167, Germany

  • Klinikum der LMU München, Campus Großhadern, Krebszentrum München

    München, 81377, Germany

  • Lkh Salzburg - Univ. Klinikum Salzburg

    Salzburg, 5020, Austria

  • Lkh-Univ. Klinikum Graz

    Graz, 8036, Austria

  • MBAL Serdika EOOD

    Sofia, 1632, Bulgaria

  • MHAT Nadezhda

    Sofia, 1330, Bulgaria

  • Masarykuv onkologicky ustav

    Brno, 656 53, Czechia

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • North Estonia Medical Centre, Oncology and hematology Clinic

    Tallinn, 13419, Estonia

  • Oncocenter Timisoara

    Timi?oara, 300166, Romania

  • Oncomedica S.A.

    Montería, 230002, Colombia

  • Oncosalud Sac

    Lima, 41, Peru

  • Onkologisches Zentrum - Onkologie Dachau

    Dachau, 85221, Germany

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Oslo universitetssykehus HF, Ullevål, Kreftsenteret

    Oslo, 0450, Norway

  • Policlinico Univ. - A.O. Mater Domini

    Catanzaro, Calabria, 88100, Italy

  • RED-Oncology GmbH

    Oldenburg / Holstein, 23758, Germany

  • Rabin MC

    Petah Tikva, 4941492, Israel

  • Ramathibodi Hospital;Medicine/Oncology

    Bangkok, 10400, Thailand

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079, Latvia

  • Royal United Hospital

    Bath, BA1 3NG, United Kingdom

  • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

    Heilbronn, 74078, Germany

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752, South Korea

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • St Vincent'S Uni Hospital

    Dublin, D04 T6F4, Ireland

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 30-688, Poland

  • Sørlandet Sykehus Kristiansand

    Kristiansand, 4604, Norway

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906, Israel

  • Theagenio Anticancer Hospital

    Thessaloniki, 540 07, Greece

  • Torbay Hospital

    Torquay, TQ27AA, United Kingdom

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030, Turkey (Türkiye)

  • U. O. Oncologia Medica, Ospedale Santa Chiara

    Pisa, Basilicate, 56100, Italy

  • Uni Hospital of Ioannina

    Ioannina, 455 00, Greece

  • Univ General Hosp Heraklion

    Heraklion, 711 10, Greece

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Frankfurt, UCT

    Frankfurt, 60590, Germany

  • Universitätsklinikum Jena, Klinik für Innere Medizin II

    Jena, 07740, Germany

  • Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie

    Münster, 48149, Germany

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Waterford Regional Hospital

    Waterford, X91 ER8E, Ireland

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Ziekenhuis VieCuri Medisch Centrum

    Venlo, 5912 BL, Netherlands

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