Clinical trials: De-escalation Therapy
Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer
A Study Testing if Patients With Advanced Prostate Cancer Who Are Responding Well to Combination Treatment Can Safely Reduce Their Medication to a Single Hormone Therapy, Compared to Continuing Their Current Drugs
The goal of this randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself…
- Trial name
- STEPDOWNmHSPC (NCT07838753)
- Testing
- De-escalation strategy, Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses
- Where
- India
- Volunteers
- 170 people
- Sponsor
- Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen [PSMA]-617) for treating patients with castration-resistant prostate cancer that has spread from where…
- Trial name
- NCT06200103
- Testing
- Biospecimen Collection, Bone Scan, Clinical Observation
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Mayo Clinic
Metastases to Bone
Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
A single centre, non-profit, randomised, unblinded pilot study on volume definition for spinal stereotactic body radiation therapy treatment. Randomization will be 1:1 between two types of SBRT treatment for spinal metastases.
- Trial name
- REVOL-SPINE (NCT07538024)
- Testing
- Stereotactic Body Radiation Therapy (SBRT) in control arm, Stereotactic Body Radiation Therapy (SBRT) in experimental arm
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
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
Breast Neoplasms, HER2-positive Breast Cancer
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab.
- Conditions
- Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell
- Trial name
- HER2Cell (NCT04993014)
- Testing
- Pertuzumab, Trastuzumab, Circulating tumor cells
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- AC Camargo Cancer Center
Human Papilloma Virus, Squamous Cell Carcinoma
De-Escalation Therapy for Human Papillomavirus Negative Disease
This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the…
- Conditions
- Human Papilloma Virus, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, HPV-Related Squamous Cell Carcinoma
- Trial name
- DEPEND (NCT03944915)
- Testing
- Carboplatin, Paclitaxel, Nivolumab
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
Nasopharyngeal Cancinoma (NPC)
Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.
To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).
- Trial name
- NCT07201337
- Testing
- Radiation Therapy
- Where
- 6 sites in China
- Volunteers
- 700 people
- Sponsor
- Sun Yat-sen University
Antibiotic Stewardship
The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
The objective of this study is to implement an opt-out protocol to guide appropriate de-escalation of antibiotics in qualifying patients.
- Trial name
- NCT03517007
- Testing
- Opt-Out Protocol
- Where
- 10 sites in United States
- Volunteers
- 762 people
- Sponsor
- Duke University
Breast Cancer, HER2 + Breast Cancer
Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the…
- Conditions
- Breast Cancer, HER2 + Breast Cancer, HR Positive, Neoadjuvant Therapy
- Trial name
- VIOLET (NCT07428018)
- Testing
- Abemaciclib
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Ulcerative Colitis (UC)
STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on…
- Trial name
- NCT06693310
- Testing
- de-escalation or discontinuation of therapy, continuation of current therapy
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Chicago
HER2-positive Breast Cancer
De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast
High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients.
- Trial name
- neoDIRHP (NCT07748260)
- Testing
- THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg), THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)
- Volunteers
- 592 people
- Sponsor
- Guangdong Provincial People's Hospital
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
Dual Antiplatelet Therapy, Acute Coronary Syndrome
De-escalating Antiplatelet Therapy to Assess Platelet Reactivity and Outcomes in High Bleeding Risk Patients With Recent ACS
High bleeding risk (HBR) patients, comprising up to 50% of those presenting with acute coronary syndrome (ACS), are a high-risk group that is increasing in size due to an aging population.
- Conditions
- Dual Antiplatelet Therapy, Acute Coronary Syndrome, Coronary Artery Disease
- Trial name
- DESC-HBR (NCT05903976)
- Testing
- P2Y12 inhibitor de-escalation
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Leukemia, Myelodysplastic Syndromes
Monoclonal Antibody Therapy in Treating Patients With Myelodysplastic Syndrome or Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Trial name
- NCT00002890
- Testing
- lintuzumab
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Crohn Disease (CD), Ulcerative Colitis (UC)
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
- Trial name
- NCT07303686
- Testing
- Ustekinumab 90 mg SC q8w, Ustekinumab 90 mg SC q12w
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Head-and-neck Squamous Cell Carcinoma
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the…
- Trial name
- DELPHI (NCT03396718)
- Testing
- De-escalation radio(chemo)therapy - Level 1, De-escalation radio(chemo)therapy - Level 2, Standard radio(chemotherapy)
- Where
- 10 sites in Germany
- Volunteers
- 304 people
- Sponsor
- Technische Universität Dresden
Oropharyngeal Cancers, HPV
Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy.
- Conditions
- Oropharyngeal Cancers, HPV, Tonsil Cancer, Base of Tongue Cancer
- Trial name
- Lombardi197 (NCT06902623)
- Testing
- Radiation
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Georgetown University
Ischemic Stroke, Transient Ischemic Attack
Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke
This is a randomized, controlled, outcome assessor blind, parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is to compare the efficacy…
- Trial name
- DEDAPT-TICA (NCT06653348)
- Testing
- Ticagrelor 60 + Aspirin, Ticagrelor 90 + aspirin
- Where
- Iran
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mazandaran University of Medical Sciences
Metastatic NSCLC
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC.
- Trial name
- DIAL (NCT05255302)
- Testing
- Pembrolizumab before randomization, Chemotherapy, Pemetrexed
- Where
- 44 sites in France
- Volunteers
- 1,360 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Coronary Artery Disease, Coronary Artery Bypass Grafting
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlled trial.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding
- Trial name
- TOP-CABG (NCT05380063)
- Testing
- De-escalated Dual Antiplatelet Therapy, Dual Antiplatelet Therapy
- Where
- China
- Volunteers
- 2,300 people
- Sponsor
- China National Center for Cardiovascular Diseases