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Tests treatment safety and results for Rectal Cancer
Official title A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
ClinicalTrials.gov ID: NCT05939661
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer
- Phase 2: a mid-size study of how well it works
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
- 1\. The patient has been fully informed of the contents of the study and has given written consent. 2\. The patient has adenocarcinoma of the rectum...
- Neutrophil count: greater than or equal to 1,500/mm3
- Platelet count: \>= 10.0 x 104 /mm3
- Hemoglobin concentration: \>=9.0 g/dL
- Total bilirubin: 1.5 times or less than the upper limit of the institutional standard
You likely can't join if
- 1\. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy
- extensive surgery (excluding CV port placement) within 4 weeks
- Any anticancer therapy within 4 weeks
- Radiation within 4 weeks 2. concomitant or pre-existing severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.)...
See the full eligibility criteria
- 1\. The patient has been fully informed of the contents of the study and has given written consent. 2\. The patient has adenocarcinoma of the rectum confirmed by histological examination. 3\. No distant metastases are...
- Neutrophil count: greater than or equal to 1,500/mm3
- Platelet count: \>= 10.0 x 104 /mm3
- Hemoglobin concentration: \>=9.0 g/dL
- Total bilirubin: 1.5 times or less than the upper limit of the institutional standard
- AST, ALT, ALP: 2.5 times or less than the upper limit of the institutional standard
- Serum creatinine: 1.5 times or less than the upper limit of the institutional standard or creatinine clearance: 45 mL/min or more
- 1\. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy
- extensive surgery (excluding CV port placement) within 4 weeks
- Any anticancer therapy within 4 weeks
- Radiation within 4 weeks 2. concomitant or pre-existing severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.) 3. patients who have had a colonic stent implanted 4. patients with...
The study team makes the final eligibility decision.
Where it's taking place
- Osaka, Japan
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Osaka, Japan. 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.