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

78

20/073

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

Ej tillä

2020-04-28

Caroline Nordenvall

Madelene Ahlberg

0

90

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

62

20/075

CITCCA pilot. CIrculating Tumour DNA in Colorectal CAncer, pilotstudie

Ej tillä

2020-10-22

Anna Martling

Madelene Ahlberg

50

57

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

19

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

20

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

78

19/044

SCAN-Mi-studien-cervix. The communication between the microbiota and biomarkers in cervical cancer

Ej tillä

2021-05-01

Kolbrun

Perihan Inekci

100

5

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

62

19/050

RUBY. A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF DOSTARLIMAB (TSR-042) PLUS CARBOPLATIN-PACLITAXEL VERSUS PLACEBO PLUS CARBOPLATIN-PACLITAXEL IN PATIENTS WITH RECURRENT OR PRIMARY ADVANCED ENDOMETRIAL CANCER

2-3

2020-07-02

Caroline Lundgren

Birgitta Nässen

10

6

20/011

Keynote-A18. A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)

3

2020-08-31

Kristina Hellman

Jenny Johansson

4

4

20/088

KEYNOTE- B21/ GOG.3053. A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053).

3

2021-09-01

Caroline Lundgren

Jenny Johansson

35

2

21/019

AGO-OVAR 2.29 / ENGOT-ov34. Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer – a randomized Phase III trial

3

2021-12-15

Josefin Fernebro

Birgitta Nässén

0

2

Prostatacancer

 Nr Namn

Fas

Startdatum Ansvarig prövare Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

14/01

PROCEED-studien. Mäns upplevelser i samband med livsförlängande behandling vid metastaserad prostatacancer, som inte längre är känslig för hormonbehandling

Ej tillä

2015-02-12

Khairul Majumder

Katrin Fines

100

46

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

53

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

149

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

Lisa Corestav

20

21

20/042

AMPLITUDE. A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

3

2021-03-16

Enrique Castellanos

Jessica Sander

5

1

21/006

PSMA Fore. Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Novel Androgen Axis Drugs in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer

3

2021-08-29

Enrique Castellanos

Sara Rydén

4

4

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

3

21/031

Aramis ROS. An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

3

2021-04-01

Enrique Castellanos

Amanda Hallgren

1

1

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

7

21/029

TROPICS-04. Phase III Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer

3

2022-03-18

Anders Ullén

Jenny Johansson

3

0

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

5

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

Lisa Corestav

150

49

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

Anna Thor

Josephine Johansson/Katrin Fines

250

217

19/002

TINCA II - njurcancer. Det immunologiska landskapet i njurcancer

Ej tillä

2021-09-01

Ulrika Harmenberg

Katrin Fines

100

11

20/061

Keynote- 012 studien. An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with MK-6482 and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as Firstline Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

3

2021-11-12

Fernanda Costa Svedman

Sara Severin

6

2

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 eller kombinationer av dessa.
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 21.05.2022