Clinical trials: De-escalation
Barrett Esophagus
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's…
- Trial name
- NCT03311451
- Testing
- C2 CryoBalloon 180° Ablation System
- Where
- 6 sites in Netherlands
- Volunteers
- 62 people
- Sponsor
- Merit Medical Systems, Inc.
Pre-menopausal Breast Cancer, PI3K Pathway Inhibition
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy…
- Trial name
- B-YOND (NCT02058381)
- Testing
- alpelisib (BYL719), buparlisib (BKM120)
- Where
- 15 sites in Hong Kong, South Korea and 2 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, HER2-positive Breast Cancer
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease…
- Trial name
- HEROES (NCT06450314)
- Testing
- Discontinuation of the anti-HER2 maintenance therapy, Monitoring with signatera test
- Where
- France
- Volunteers
- 170 people
- Sponsor
- UNICANCER
Lymphadenectomy, Endometrial Cancer
SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial
This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations.
- Conditions
- Lymphadenectomy, Endometrial Cancer, Gene, p53, Sentinel Lymph Node Biopsy (SLNB)
- Trial name
- SENTIMETREP53 (NCT06900582)
- Testing
- Sentinel Lymph Node Mapping, Comprehensive pelvic and para-aortic lymphadenectomy
- Volunteers
- 374 people
- Sponsor
- University Hospital, Strasbourg, France
Oropharyngeal Cancer, Squamous Cell Carcinoma of the Oropharynx
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation…
- Trial name
- NCT05894083
- Testing
- Surgery, Chemoradiation, Observation
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Michigan Rogel Cancer Center
Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
This phase Ib trial is to find out the best dose and side effects of all-trans retinoic acid (ATRA) and atezolizumab in treating patients with non-small cell lung cancer that has come back (recurrent) or has spread to other…
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8
- Trial name
- NCT04919369
- Testing
- Atezolizumab, Tretinoin
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Dwight Owen
Brest Cancer ER+ and HER2 Negative
De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer
This study is a randomized, open-label, phase II trial designed to evaluate whether alternate-day dosing of letrozole preserves antiproliferative activity compared with standard daily dosing in postmenopausal women with estrogen…
- Trial name
- DELTA (NCT07866430)
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
TNBC, Triple Negative Breast Cancer
TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer
Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder…
- Trial name
- TREND-02 (NCT07271992)
- Testing
- SG+I
- Volunteers
- 30 people
- Sponsor
- First Hospital of China Medical University
Prostate Cancer, Prostate Adenocarcinoma
A Study of Lower Dose Radiation Therapy for People With Prostate Cancer
The purpose of this study is to see whether giving a lower (de-escalated) dose of radiation therapy to some parts of the prostate can reduce side effects compared to giving the same (uniform) dose of radiation therapy to the…
- Trial name
- NCT07635238
- Testing
- MR-guided Stereotactic Body Radiation Therapy
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Myelodysplastic Syndromes
Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00503880
- Testing
- filgrastim, clofarabine, cytarabine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Nebraska
Malaria
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali
Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death.
- Trial name
- NCT03917654
- Testing
- Pfs230D1M-EPA/AS01, HAVRIX, TYPHIM Vi (Salmonella typhi vaccine)
- Where
- Mali
- Volunteers
- 1,301 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Breast Cancer, HER2-positive Breast Cancer
De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer
This phase II study evaluates the efficacy and safety of a de-escalated neoadjuvant chemotherapy regimen in patients with early-stage HER2-positive breast cancer.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Early Breast Cancer
- Trial name
- Opti-HER2 (NCT07421141)
- Testing
- Paclitaxel, trastuzumab, Pertuzumab
- Where
- Russia
- Volunteers
- 186 people
- Sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
Acute Coronary Syndrome, Coronary Artery Disease
IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS
We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications.
- Trial name
- NCT04848766
- Testing
- De-escalation Treatment Strategy of dual antiplatelet therapy
- Where
- South Korea
- Volunteers
- 9,000 people
- Sponsor
- Seoul National University Hospital
Gastric-Esophageal Cancer
Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer
The goal of this clinical trial is to assess if circulating tumor DNA, as assessed by Signatera tumor-informed MRD assay, can guide de-escalation of adjuvant therapy in patients with resectable Stage II-IVa…
- Trial name
- SIGNAL GEC-101 (NCT07565857)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 1,000 people
- Sponsor
- Natera, Inc.
Unresectable Stage IIIB-IV Malignant Melanoma
Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant…
- Trial name
- NCT03064763
- Testing
- Talimogene laherparepvec
- Where
- 9 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Amgen
Stage I Breast Cancer
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with…
- Trial name
- DEBRA (NCT04852887)
- Testing
- Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Where
- 832 sites in United States, Canada and 2 more
- Volunteers
- 1,670 people
- Sponsor
- NRG Oncology
Diabetes type2
Impact of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification
Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags…
- Trial name
- NCT03958591
- Testing
- CSII and thereafter combination therapy, followed up with wearable devices, CSII and thereafter combination therapy, Basal insulin treatment without wearables
- Where
- China
- Volunteers
- 276 people
- Sponsor
- Yanbing Li
Breast Cancer
DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC
This research study is studying whether participants and their doctors are willing to determine post-surgery treatment on the basis of response to pre-surgery treatment, and studying blood and tissue collected from participants…
- Trial name
- NCT03716180
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Dana-Farber Cancer Institute
Measles, Rubella
Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
This is a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial. Age de-escalation will be based on a review of the safety data from the preceding cohort (adults for toddlers…
- Conditions
- Measles, Rubella, Vaccination, Healthy
- Trial name
- NCT04394689
- Testing
- Measles Rubella Vaccine (MRV-SC), MRV-MNP, PLA-MNP
- Where
- The Gambia
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- Micron Biomedical, Inc
Head and Neck Squamous Cell Carcinoma
The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete…
- Trial name
- NCT05854823
- Testing
- dose-reduced radiotherapy
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University