BridgeMD
New treatment option for Esophageal Cancer
Official title A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT05370144
What this study is testing
- What it's testing
- An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.
- Time commitment: about 1 week
- 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 to 80
You may be able to join if
- Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
- Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
- Maximum length (based on best information available, with EGD preferred) and width of the tumor as seen on CT not exceeding 8 cm and 5 cm...
- ECOG performance status ≤ 2
- Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
You likely can't join if
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated carcinoma in situ of...
- Previous chemotherapy and radiotherapy
- New York heart Association Class III/IV and no history of active angina. Documented myocardial infarction within the 6 months preceding registration...
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
See the full eligibility criteria
- Biopsy-proven invasive adenocarcinoma of the esophagus or GEJ (Siewart type I-II)
- Surgically resectable clinical stage T1N1-3 or T2-3N0-3 and no clinical evidence of metastatic spread are eligible (M0).
- Maximum length (based on best information available, with EGD preferred) and width of the tumor as seen on CT not exceeding 8 cm and 5 cm respectively.
- ECOG performance status ≤ 2
- Patient able to begin radiation treatment within 30 calendar days of signing the informed consent form.
- Age ≥ 18 and ≤ 80.
- Adequate hematological, renal, hepatic and pulmonary function as defined by:
- Hemoglobin \> 100 g/L
- Platelet count \> 100x109/L
- Absolute neutrophil count \> 1.5x109/L
- Total bilirubin ≤ 1.5x the upper limit of institutional normal
- Creatinine ≤ 120 µmol/L
- FEV1 ≥ 1.5 L
- Patients capable of childbearing are using adequate contraception.
- Written and informed consent of patient.
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated carcinoma in situ of the cervix or a cured malignancy more than 5 years prior to enrollment
- Previous chemotherapy and radiotherapy
- New York heart Association Class III/IV and no history of active angina. Documented myocardial infarction within the 6 months preceding registration (pretreatment echocardiogram evidence of infarct only will not exclude...
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Weight loss \> 20% within 3 months of the date of screening
- Esophageal stent
- Pregnant or lactating patients; women of childbearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit 1. Women or men of childbearing potential must use effective contraception...
- Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
- Unable to complete surveys in English without aid of interpreter.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 1 week 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. 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.