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New treatment option for Rectal Cancer
Official title Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer
ClinicalTrials.gov ID: NCT05136326
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an infusion into a vein, 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
- In patients with locally advanced rectal cancer (LARC), preoperative chemo-radiotherapy (CTRT) is considered the standard of care. Preoperative CTRT approach often results in a significant tumor downstaging and local control, with evidence of complete pathological response (pCR) rate of about 15% in high volume institutions.
- 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
- Written informed consent to study procedures;
- Willing and able to comply with the protocol;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;
- Life expectancy of at least 5 years (excluding diagnosis of cancer);
You likely can't join if
- Dihydropyrimidine dehydrogenase (DPD) deficiency;
- Previous pelvic RT;
- Any of the following in the 6 months prior to treatment start: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass...
- Uncontrolled coagulopathy;
- Active infection requiring systemic therapy;
- Infection with human immunodeficiency virus (HIV) plus CD4 cells \<200/mm3 or AIDS-defining conditions despite HAART;
See the full eligibility criteria
- Written informed consent to study procedures;
- Willing and able to comply with the protocol;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;
- Life expectancy of at least 5 years (excluding diagnosis of cancer);
- Histologically confirmed diagnosis of rectal adenocarcinoma, with centrally confirmed mismatch repair proficiency (MSS) by PCR, lack of MGMT expression by IHC and MGMT promoter methylation by pyrosequencing;
- Locally advanced, resectable disease defined by the presence of at least one of the following features:
- Distal tumor margin at \<15 cm from the anal verge;
- cT3N0 or cT1-3N1 (with the definition of a clinically positive lymph node being any node ≥ 1 cm);
- Less than four lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease;
- No evidence of enlarged lateral pelvic clinically positive lymph node (\> 1 cm);
- No evidence of extramural vascular invasion (EMVI);
- No evidence of metastatic disease by CT scan of the chest and abdomen and total body fluorodeoxyglucose positron emission tomography (FDG-PET)/CT scan;
- No clear indication of involvement of the pelvic side walls by imaging;
- Tumor must be amenable to curative resection (curative resection can include pelvic exenteration);
- Hematopoietic: absolute neutrophil count ≥1500/mm3; platelet count ≥ 100,000/mm3; haemoglobin level ≥ 10 g/dL;
- Hepatic total bilirubin ≤1.5 time upper limit of normal (ULN); alkaline phosphatase ≤ 2 times ULN; AST and ALT ≤ 2.5 times ULN Serum creatinine ≤ 1.5 × ULN or renal creatinine clearance ≥ 50 mL/min according to the...
- Availability of an adequate archival tumor sample (Formalin Fixed Paraffin-embedded [FFPE]) for central tissue screening. If the tumor block is not available, a minimum of twenty-five (25) 3-micron unstained sections of...
- Male people with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator (barrier contraceptive measure or oral contraception) contraception starting with...
- Women of childbearing potential must have a negative blood pregnancy test at the baseline visit and must be willing to use an effective means of contraception and to continue its use for the duration of the study and...
- Dihydropyrimidine dehydrogenase (DPD) deficiency;
- Previous pelvic RT;
- Any of the following in the 6 months prior to treatment start: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (≥ New York Heart Association...
- Uncontrolled coagulopathy;
- Active infection requiring systemic therapy;
- Infection with human immunodeficiency virus (HIV) plus CD4 cells \<200/mm3 or AIDS-defining conditions despite HAART;
- Known prior severe hypersensitivity to investigational product or any component in its. formulations;
- Lack of upper gastrointestinal tract integrity or malabsorption syndrome; immune colitis; active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic);
- Presence of metastatic disease, recurrent rectal cancer or history of invasive rectal malignancy, regardless of disease-free interval;
- Other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell or cloacogenic carcinoma) or synchronous colon cancer;
- Patients with prior malignancies, including invasive colon cancer, are eligible provided they have been disease-free for ≥ 3 years and are deemed by their physician to be at low risk for recurrence (patients with...
- Other severe acute or chronic medical conditions including immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory...
- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies;
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
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 Milan, Italy. 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.