Kliniska studier vid Tema Cancer

–Studier öppna för inklusion inom PO Bäckencancer–

Här visas de studier som är öppna för patientinklusion inom den medicinska enheten (ME). Studierna är uppdelade på de olika patientflödena. Vidare visas ansvarig prövare, forskningssjuksköterska och planerad och aktuell inklusion inom temat (visas ej utanför Karolinska). Listan uppdateras minst en gång i veckan. -Längst ner finns en förklaring till de olika kolumnerna.

Kolorektal cancer

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

17/314

Watch and wait. Watch and wait-Icke operativ behandling vid strål- och cellgiftsbehandling.

Ej tillä

2016-08-08

Anna Martling

Shahrzad Kordnejad

0

132

20/038

SOULMATE. The Swedish study of liver transplantation for non-resectable/non-ablatable colorectal liver metastases.

2

2021-04-01

Mia Karlberg

Birgitta Nässen

10

0

20/073

CIM-HIPEC. The native immune system and the development of carcinomatosis among patients with colorectal cance

Ej tillä

2020-01-10

Caroline Nordenvall

Madelene Ahlberg

0

139

20/074

CIM-IBD. Single-cell analysis of intestinal lymphocytes reveals targets for treatment of inflammatory bowel disease

Ej tillä

2019-06-13

Caroline Nordenvall

Madelene Ahlberg

0

109

20/075

CITCCA pilot. CIrculating Tumour DNA in Colorectal CAncer, pilotstudie

Ej tillä

2020-10-22

Anna Martling

Madelene Ahlberg

50

109

20/076

CRUISE. Restorative treatment with ileorectal anastomosis or ileal pouch anal anastomosis in patients with ulcerative colitis

Ej tillä

2017-03-01

Caroline Nordenvall

Madelene Ahlberg

0

39

20/077

EROS. Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized controlled study with tadalafil compared to standard care

2-3

2020-11-01

Christian Buchli

Hanna Rosén

50

53

21/046

EFFIPEC. EFFIPEC – Efficacy of Hyperthermic Intraperitoneal Chemotherapy Single-arm Phase I study, followed by an open-label, randomized, controlled registry-based phase III trial

1

2022-10-30

Gabriella Palmer

Birgitta Nässén

10

9

21/082

Breakwater. An open-label , multicenter , randomized, phase 3 study of first-line encorafenib plus cetuximab with or without chemotherapy versus standard of care therapy with a safety lead-in of encorafenib and cetuximab plus chemotherapy in participants with metastatic BRAF V600E-mutant colorectal cancer

3

2022-06-01

Sandra Andersson

Birgitta Nässén

0

0

22/019

PelvEx II. Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer

3

2022-08-17

Henrik Iversen

Malin Smedman

0

2

Gynekologisk cancer

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

18/080

RACC. The RACC trial -Robot Assisted Approach to Cervical Cancer

3

2019-05-27

Henrik Falconer

Sara Rydén

50

128

19/044

SCAN-Mi-studien-cervix. ME

Ej tillä

2021-05-01

Henrik Falconer

Perihan Inekci

100

27

19/046

IPLA-OVCA-lokalanestesi i buken. The effect of local anesthetics on morbidity, start of chemotherapy and mortality in patients undergoing cytoreductive surgery for stage III-IV ovarian cancer. Prospective, randomized, double blind, multicenter study

3-4

2020-08-24

Sahar Salehi

Jenny Johansson

120

148

19/058

TITANIUM. GestaTIonal TrophoblAstic NeoplasIa assessMent

4

0000-00-00

Ulrika Joneborg

-

0

0

21/034

DOVACC. A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients with Recurrent Ovarian Cancer

2-3

2023-01-25

Josefin Fernebro

Sara Rydén

0

3

21/107

GeMore-studien. Genetisk och molekylär kartläggning samt riktad behandling inom gynekologisk cancer

Ej tillä

2021-01-02

Josefin Fernebro

Perihan Inekci

100

150

21/108

ISGA-studien (pre-GAT01). studier av immunsystemet hos patienter med gyncancer

2021-10-21

Emelie Wallin

Perihan Inekci

50

34

22/007

KEYNOTE C93/ MK3475-C93. A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab vs. Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting

3

2022-11-01

Hanna Dahlstrand

Jenny Johansson

2

1

22/069

KANDOVA. KANDOVA - A two-part Phase Ib/IIa study to evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID)of KAND567. An open-label, multicenter dose escalation study with an expansion cohort in women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

1-2

2023-04-26

Hanna Dahlstrand

Sara Rydén

0

1

22/077

ct-DNA-studien på cervixcancer. Analys av cell-fritt tumör-DNA i blod.

Ej tillä

2022-01-01

Kristina Hellman

Perihan Inekci

100

19

23/027

iMolE. implementation of Molecular diagnosis of Endometrial cancer

Ej tillä

2023-05-23

Emelie Wallin

Perihan Inekci

0

59

Prostatacancer

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

14/37

SPCG-15. Primary radical prostatectomy versus primary radiotherapy for locally advanced prostate cancer: an open randomized clinical trial

3

2014-10-01

Mats Olsson

Jessica Sander

50

59

18/034

PSMA recidiv-studien. En randomiserad jämförelse mellan konventionell "Salvage" strålbehandling och individualiserad PSMA-pet styrd behandling hos patienter med biokemiskt återfall (PSA) efter prostatacancer operation

2

2018-10-30

Stefan Carlsson

Jessica Sander

350

171

18/066

ProBio . ProBio: An outcome-adaptive and randomized multi-arm biomarker driven study in patients with metastatic castrate resistant prostate cancer mCRPC)

2

2019-05-27

Anders Ullén

Amanda Hallgren

20

23

21/007

PSMAddition (CAAA617C12301). An International Prospective Open-label, Randomized, Phase III Study Comparing Androgen Deprivation Therapy and Novel Androgen Axis Drugs Alone or With 177Lu-PSMA-617 in Men with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

3

2021-12-17

Enrique Castellanos

Jessica Sander

0

6

21/023

MK3475-365. Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

1-2

2022-04-01

Enrique Castellanos

Katarina Hammarlund

35

1

21/048

PRIS. Prostate Cancer IRE Study (PRIS) – A randomized controlled trial comparing focal to radical treatment in localized prostate cancer

Ej tillä

2022-09-07

Anna Lantz

Malin Smedman

184

22

Blåscancer

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

19/056

KEYNOTE 905. A Phase 3 Randomized Study of Cystectomy plus Perioperative Pembrolizumab versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscleinvasive Bladder Cancer

3

2019-11-11

Anders Ullén

Katarina Hammarlund

6

12

21/041

BioBladder. Biomarker profiling to predict response and survival in patients receiving systemic therapy for advanced urothelial cancer

Ej tillä

2022-03-10

Anders Ullén

Katrin Fines

60

73

21/067

RWD Avelumab. A Swedish nationwide real-world data study of maintenance avelumab in patients with advanced urothelial cancer without progression following first-line platinum-based chemotherapy

4

2022-08-15

Anders Ullén

Faith Jawdat

0

0

21/089

NORTH-REG Dwell Time Study. NORTH-REG Dwell Time Study

4

2022-04-08

Tomas Thiel

Janelle Cederlund

20

10

22/023

XNK urotelialcancer. Analys av immunceller från patienter med urotelial cancer i syfte att förbättra immunoterapier

Ej tillä

2022-11-21

Fernanda Costas Svedman

Katrin Fines

10

13

Njur- och testikelcancer

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

14/43

ABC-studien. A randomizes phase III study comparing one course of adjuvant Bleomycin,Etoposid and Cisplatin (BEP)and one course of carboplatin AUC7 in clinical stage I seminomatous testicular cancer

3

2015-11-01

Gabriella Cohn-Cedermark

Amanda Hallgren

150

64

18/016

MIR-Studien . MikroRNA som markörer för monitorering av sjukdomsaktivitet, utvärdering av effekt av cytostatikabehandling, samt verktyg för tidig upptäckt av recidiv av metastatisk testikelcancer. Implentering av MIR-Studien

Ej tillä

2019-04-23

Anders Kjellman

Josephine Johansson/Katrin Fines

250

290

19/002

TINCA II - njurcancer. Det immunologiska landskapet i njurcancer

Ej tillä

2021-09-01

Ulrika Harmenberg

Katrin Fines

100

35

21/093

MK-6482-022. A Multi-center, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) plus Pembrolizumab (MK- 3475) Versus Placebo plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (6482-022)

3

2023-04-01

Fernanda Costa-Svedman

Helena Forsén

6

3

Urologiska sjukdomar

Tyvärr är inga studier aktuella just nu.

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara Fas 1, 2, 3 eller Pilot, kombinationer av dessa, eller Ej tillämpligt.
Startdatum: Vanligen datum för startmöte eller liknande.
Ansvarig prövare: Den läkare som är ansvarig för studien inom Tema Cancer.
Ansvarig forskn.sköt: Den forskningssjuksköterska som är ansvarig.

CKC, Tema Cancer, Karolinska universitetssjukhuset 28.03.2024