Ongoing Clinical Trials for Rectal Cancer Stage III
There are currently 4 ongoing clinical trials for patients with stage III rectal cancer. These studies are testing different treatment combinations including short-course radiotherapy, chemotherapy regimens, and immunotherapy approaches. Trials are being conducted in Belgium, Germany, and Italy, exploring ways to improve treatment outcomes for patients with locally advanced disease.
Clinical trial locations
- Belgium
- Germany
- Italy
Study Comparing Short-Course Radiotherapy and Drug Combination for Older Patients with Locally Advanced Rectal Cancer
This trial is specifically designed for older patients aged 70 years and above with locally advanced rectal cancer. The study compares two different treatment approaches to determine which offers the best balance between effectiveness and safety for this age group.
Main inclusion criteria: Patients must be 70 years or older with confirmed adenocarcinoma of the rectum located within 15 cm of the anal verge. The cancer must be operable stage III or high-risk stage II. Participants need adequate bone marrow, liver, and kidney function, with specific blood count requirements including absolute neutrophil count of 1,500/µL or more, hemoglobin of 9 g/dL or more, and platelets of 100,000/µL or more. Performance status requirements vary by age, with those over 75 needing an ECOG score of 0 or 1, while those 75 or younger may have scores of 0, 1, or 2.
Main exclusion criteria: Patients with any other type of cancer, those who have had previous treatment for rectal cancer, severe heart problems, uncontrolled high blood pressure, severe liver or kidney disease, active infections, pregnancy or breastfeeding, or those participating in another clinical trial are excluded.
Study focus: The trial aims to compare short-course radiotherapy followed by surgery (with or without additional chemotherapy) against total neoadjuvant therapy, which involves a combination of treatments given before surgery. The goal is to assess overall survival, progression-free survival, and side effects to identify the optimal treatment strategy for older patients.
Investigational treatments: The study uses short-course radiotherapy and various chemotherapy medications including Capecitabine, Oxaliplatin, and Fluorouracil. Supportive medications such as Ondansetron, Dexamethasone, Folinic Acid, and Metoclopramide are also administered to manage side effects.
Study of Regorafenib and Nivolumab with radiotherapy for patients with stage II-III rectal cancer before surgery
This Belgian trial combines immunotherapy and targeted therapy with radiotherapy in a novel treatment approach for stage II-III rectal cancer patients with specific tumor characteristics.
Main inclusion criteria: Participants must be at least 18 years old with confirmed rectal adenocarcinoma located within 15 cm from the anal opening and below the peritoneal fold. Patients must have good overall physical condition with an ECOG score of 0-1 and a life expectancy of at least 3 months. Adequate kidney function, liver function, and blood cell counts are required, including sufficient white blood cells, platelets, and hemoglobin. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 7 months after, while men with partners who can become pregnant must use condoms during the study and for 5 months after.
Main exclusion criteria: The trial excludes patients who have received prior cancer treatment for rectal cancer, those with active or untreated brain metastases, known autoimmune disease, active infections requiring systemic treatment, history of organ transplant, uncontrolled high blood pressure or significant heart disease, major recent surgery, active bleeding or high bleeding risk, pregnancy or breastfeeding, known allergy to study medications, or participation in another clinical trial within 28 days.
Study focus: The primary aim is to determine if the combination of regorafenib, nivolumab, and short-course radiotherapy can achieve a complete response in patients whose tumors have specific characteristics (pMMR/MSS tumors), meaning no signs of cancer remain after treatment.
Investigational treatments: Regorafenib is a kinase inhibitor taken as tablets (maximum daily dose of 60 mg) that blocks proteins helping cancer cells grow. Nivolumab is an immunotherapy medication given through intravenous infusion (maximum daily dose of 240 mg) that helps the immune system fight cancer by blocking the PD-1 protein. Both are combined with short-course radiotherapy.
Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy
This German study focuses on immunotherapy treatment for patients with specific tumor characteristics who cannot receive or choose not to receive standard oxaliplatin-based chemotherapy.
Main inclusion criteria: Patients must be 18 years or older with confirmed adenocarcinoma of the colon or rectum at high-risk stage II or stage III. The tumor must be MSI-high or MMR-deficient, which are specific characteristics of the cancer cells. Participants must have had successful tumor removal surgery (R0 or mostly successful R1 resection) and have an ECOG status of 0 to 2. Patients must be unable to receive oxaliplatin-based chemotherapy or choose not to receive it. Adequate blood counts, liver enzymes, and kidney function are required, along with specific blood test results showing INR and PTT less than 1.5 times the normal limit.
Main exclusion criteria: Patients with a different type of cancer than the one being studied, those who have already received oxaliplatin-based chemotherapy, those who have not had their tumor completely removed, patients not willing to follow study procedures, those with other serious health conditions, pregnancy or breastfeeding, participation in another clinical trial, known allergy to the study medication, active infections, or various histories of heart, lung, liver, kidney, immune system, neurological, or psychiatric conditions are excluded.
Study focus: The main goal is to evaluate whether atezolizumab can improve the disease-free survival rate at 3 years compared to placebo in patients with MSI-high or MMR-deficient colorectal cancer who are not suitable for standard chemotherapy.
Investigational treatment: Atezolizumab is an immune checkpoint inhibitor given as an intravenous infusion that works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells. The study will compare atezolizumab treatment with a placebo over a treatment period of up to 12 months.
Study on Short-Course Radiotherapy and Chemotherapy with Fluorouracil, Irinotecan, and Oxaliplatin for Patients with Locally Advanced Rectal Cancer
This Italian trial investigates a combination approach starting with short-course radiotherapy followed by intensive chemotherapy using the FOLFOXIRI regimen for locally advanced disease.
Main inclusion criteria: Patients must be between 18 and 70 years old with confirmed rectal adenocarcinoma and locally advanced disease featuring at least 4 positive lymph nodes on pelvic MRI, tumor extending to or beyond the mesorectal fascia, or specific tumor stages (cT4 or cT3, N1). The lower edge of the tumor should be located between 5 and 12 cm from the anal verge. Participants must have an ECOG performance status of 0 or 1 and no evidence of cancer spread to other body parts. Adequate blood health is required with absolute neutrophil count of at least 1,500 per mm3, platelet count of at least 100,000 per mm3, and hemoglobin level of at least 9 g/dL. Liver and kidney function must meet specific requirements, and life expectancy should be at least 5 years. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
Main exclusion criteria: Patients with other types of cancer besides locally advanced rectal cancer, those outside the specified age range, inability to provide informed consent, pregnancy or breastfeeding, certain medical conditions that might interfere with the study (such as serious heart, lung, or other organ problems), and current participation in another clinical trial.
Study focus: The trial evaluates the effectiveness of combining short-course radiotherapy with the FOLFOXIRI chemotherapy regimen in achieving a complete response, defined as the absence of cancer cells in tissue removed during surgery. The approach aims to shrink the tumor before surgery and improve treatment outcomes.
Investigational treatments: Short-course radiotherapy is used first to target and reduce tumor size. This is followed by consolidation chemotherapy with the FOLFOXIRI regimen, which includes Fluorouracil, Irinotecan, Oxaliplatin, and Calcium Levofolinate, all administered through intravenous infusion. These drugs work together to interfere with DNA replication in cancer cells, inhibiting their growth and spread.
Summary
The four ongoing clinical trials for stage III rectal cancer reflect diverse treatment approaches tailored to different patient populations. Two trials are being conducted in Belgium, focusing on older patients and immunotherapy combinations, while Germany and Italy each host one trial exploring immunotherapy and intensive chemotherapy regimens respectively.
A notable trend is the emphasis on short-course radiotherapy combined with various systemic treatments. Three of the four trials incorporate this approach, suggesting its importance in modern treatment strategies. The trials also demonstrate increasing interest in immunotherapy, with two studies investigating immune checkpoint inhibitors (nivolumab and atezolizumab) for specific patient subgroups, particularly those with certain tumor characteristics or those unable to receive standard chemotherapy.
The studies address different patient needs: one specifically targets older patients aged 70 and above, another focuses on patients with MSI-high or MMR-deficient tumors who cannot receive oxaliplatin, while others explore novel drug combinations for broader patient populations. This variety ensures that research is progressing across multiple treatment avenues, potentially offering more personalized options for patients with locally advanced disease in the future.
