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. |
Akt. |
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. |
Akt. |
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. |
Akt. |
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. |
Akt. |
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. |
Akt. |
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