Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer (PEMREC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04109755|
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rectum Cancer Rectal Cancer||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate Safety and Efficacy of Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer|
|Actual Study Start Date :||June 2, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||March 2028|
Short Course Radiation Therapy (5 x 5 Gy in 1 week, SCRT) with 4 injections of Pembrolizumab starting on the first day of radiotherapy and surgery
5x5 Gy radiotherapy in 1 week, 4 cycles of Pembrolizumab (200 mg every three week), surgery
- Tumour regression grade [ Time Frame: 12 weeks after start ]To assess the tumour regression grade (TRG) after short course radiotherapy when given together with pembrolizumab, using the Mandard regression grade score
- Tolerability and safety [ Time Frame: 5 years ]To assess tolerability and safety of pembrolizumab given with short course radiotherapy before surgery, using the common terminology criteria for adverse events (CTCAE) Version 4.0
- Overall Survival [ Time Frame: 5 years ]To estimate overall survival (OS), defined as the time between the date of the study entry and the date of death due to any cause. Subjects who have not died at the time of last known follow-up will be censored.
- Disease-free survival [ Time Frame: 3 years ]To estimate disease-free survival (DFS), defined as the time between the date of the study entry and the date of recurrence, second primary cancer, or death without evidence of recurrence or second primary cancer.
- Locoregional relapse-free survival [ Time Frame: 5 years ]To estimate locoregional relapse-free survival (LRRFS), defined as the time between the date of the surgery and local or regional recurrence. LRRFS is evaluated in patients who had an R0 resection only
- Distant metastasis-free survival [ Time Frame: 5 years ]To estimate distant metastasis-free survival (DMFS), defined as the time between the date of the surgery and metastatic recurrence.
- EORTC QLQ-C30 [ Time Frame: 30 months ]European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-C30
- EORTC QLQ-CR29 [ Time Frame: 30 months ]European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-CR29
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109755
|Contact: Thibaud Kössler, MD PhD||+41 (0)22 372 77 email@example.com|
|Contact: Sandra Bettinelli Riccardi, PhD||+41223722903||Sandra.BettinelliRiccardi@hcuge.ch|
|Hôpitaux Universitaires de Genève||Recruiting|
|Geneva, Switzerland, 1205|
|Contact: Thibaud Kössler, MD PhD firstname.lastname@example.org|