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Compares treatment options for Colon Cancer Stage II
Official title Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
ClinicalTrials.gov ID: NCT05194878
What this study is testing
What is neoadjuvant chemotherapyI?
neoadjuvant chemotherapyI is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colon cancer stage ii.
Also referred to as mFOLFOXIR.
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
- BACKGROUND: In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death.
- Phase 3: a large, late-stage study
- 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 75
You may be able to join if
- Histologically proven adenocarcinoma or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer of the colon(≥ 12...
- pMMR in immunohistochemical detection or MSI-H in MSI test.
- Determined preoperatively by either spiral or multidetector CT: high risk T3 (tumor disruption of muscle wall and extension into pericolic fat with...
- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and...
- Adequate full blood count: WBC \>3.0 x109/l; Plts \>100 x109/l. Anaemia (Hb \< 10.0 g/dl) is not an exclusion, but should be corrected by transfusion...
You likely can't join if
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (M1)
- dMMR in immunohistochemical detection or MSI-L/MS-S in MSI test.
- Peritonitis (secondary to perforated tumour)
- Colonic obstruction that has not been defunctioned
- Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (\<6 months) MI
See the full eligibility criteria
- Histologically proven adenocarcinoma or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer of the colon(≥ 12 cm from the anal verge).
- pMMR in immunohistochemical detection or MSI-H in MSI test.
- Determined preoperatively by either spiral or multidetector CT: high risk T3 (tumor disruption of muscle wall and extension into pericolic fat with more than 5 mm protrusion into adjacent mesenteric fat) or T4 (tumor...
- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility...
- Adequate full blood count: WBC \>3.0 x109/l; Plts \>100 x109/l. Anaemia (Hb \< 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite...
- Adequate renal biochemistry: serum creatinine was less than 1.5 times the normal value.
- Adequate hepatobiliary function: serum total bilirubin and ALT were less than 1.5 times the normal value.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (M1)
- dMMR in immunohistochemical detection or MSI-L/MS-S in MSI test.
- Peritonitis (secondary to perforated tumour)
- Colonic obstruction that has not been defunctioned
- Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (\<6 months) MI
- Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
- Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \<5%
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. 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.