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Compares treatment options for Advanced Anal Carcinoma
Official title At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT05969860
What this study is testing
- What it's testing
- This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging...
- Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical...
- Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving...
- Eligible disease cancer types:
- Anal cancer
You likely can't join if
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant...
- Requiring 24/7 assistance with activities of daily living (ADLs)
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for...
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
See the full eligibility criteria
Who can join
- Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.
- Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the...
- Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these...
- Eligible disease cancer types:
- Anal cancer
- Appendiceal carcinoma
- Basal cell carcinoma
- Bladder cancer
- Biliary cancer
- Breast cancer
- Central Nervous System malignancy including glioblastoma
- Cervical cancer
- Cholangiocarcinoma
- Colorectal carcinoma
- Endometrial cancer
- Fallopian tube cancer
- Gastroesophageal cancer [including gastric, esophageal, and gastroesophageal junction (GEJ) cancers]
- Germ cell carcinoma
- Head and Neck cancer
- Hepatocellular Carcinoma
- Liver
- Lung
- Lymphoma
- Melanoma
- Merkel Cell
- Multiple Myeloma
- Myelodysplastic syndrome
- Myeloid Disorders
- Neuroendocrine carcinoma
- Ovarian cancer
- Pancreatic adenocarcinoma
- Penile carcinoma
- Peritoneal carcinoma
- Prostate cancer
- Renal cell cancer
- Sarcoma
- Squamous cell Carcinoma of the Skin
- Testicular cancer
- Urethral carcinoma
- Vaginal carcinoma
- Vulvar carcinoma
- Eligible Regimens
- Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab
- 5FU +/- leucovorin +/- bevacizumab +/- nivolumab
- Atezolizumab +/- bevacizumab
- Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib
- Avelumab
- Avelumab + axitinib
- Bevacizumab
- Bevacizumab + capecitabine
- Bevacizumab + irinotecan (+/- capecitabine)
- Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib
- Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus
- Bevacizumab + trifluridine/tipiracil
- Bortezomib
- Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
- Bortezomib + venetoclax
- Carfilzomib
- Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor
- Carfilzomib + venetoclax
- Cemiplimab
- Cisplatin
- Cisplatin/5-FU
- Cisplatin/etoposide
- Cisplatin + durvalumab
- Cisplatin + gemcitabine
- Cisplatin + gemcitabine + durvalumab
- Daratumumab (+ oral [PO] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
- Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
- Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
- Degarelix
- Durvalumab
- Durvalumab + tremelimumab
- Eribulin
- FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)
- Fam-trastuzumab deruxtecan
- Fulvestrant
- Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib
- Gemcitabine
- Gemcitabine + durvalumab
- Gemcitabine + paclitaxel protein-bound
- Goserelin acetate
- Irinotecan
- Irinotecan + capecitabine
- Lanreotide
- Leuprolide
- Nivolumab
- Nivolumab + cabozantinib
- Nivolumab-relatlimab
- Octreotide
- Paclitaxel
- Pembrolizumab
- Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)
- Pemetrexed
- Pertuzumab
- Pemetrexed + pembrolizumab
- Rituximab
- Trastuzumab + paclitaxel
- Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)
- Decitabine
- These regimens can be used only if patients are receiving one of the regimens above:
- Darbepoetin-alfa
- Epoetin
- Filgrastim
- Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of...
- Zoledronic acid
- Denosumab
- Patient has had adequate side effects of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent
- Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.
- Residing within the area serviced by supplier and paramedic network
- Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution
- Age \>= 18 years at time of registration
- Signed informed consent form by patient
- Willing and able to comply with the study protocol in the investigator's judgement
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
- Ability to complete questionnaire(s) by themselves or with assistance
- RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate side effects to the standard of care cancer therapy and no drug-related...
What rules you out
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or...
- Requiring 24/7 assistance with activities of daily living (ADLs)
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper...
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction =\< 6 months
- Wound healing disorder
- Or psychiatric illness/social situations that would limit compliance with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Grand Forks, North Dakota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Grand Forks, North Dakota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.