Ongoing Clinical Trials for Rectal Cancer
There are currently 32 clinical trials investigating new treatments and approaches for rectal cancer across multiple countries. These studies range from testing innovative imaging techniques and immunotherapy combinations to comparing different chemotherapy regimens and exploring organ preservation strategies. The trials are being conducted in countries including the Netherlands, Germany, France, Italy, Spain, Belgium, Sweden, Denmark, Finland, and Ireland.
Clinical trial locations
- Belgium
- Denmark
- Finland
- France
- Study comparing preoperative drug combination with irinotecan, fluorouracil, calcium folinate and oxaliplatin for patients with locally advanced resectable rectal cancer
- Study of Dostarlimab Combined with Short Course Radiotherapy for Locally Advanced Rectal Cancer Patients with Microsatellite Instability
- Study on Early Erectile Rehabilitation with Sildenafil for Men After Rectal Cancer Surgery
- Study on Managing Locally-Advanced Rectal Cancer with Oxaliplatin, Fluorouracil, and Irinotecan Hydrochloride for Patients Responding Well to Initial Chemotherapy
- Study on Encorafenib and Cetuximab for Patients with BRAF V600E-Mutated Localized Colon or Upper Rectum Cancer
- Study on Oxaliplatin and Irinotecan for Patients with Metastatic Colorectal Cancer in the Liver
- Study on Chemotherapy and Pelvic Reirradiation for Patients with Recurrent Rectal Cancer Using Irinotecan, Levoleucovorin, Fluorouracil, Oxaliplatin, and Capecitabine
- Study Comparing Surgery and Chemoradiotherapy with Capecitabine for Early Rectal Cancer Patients
- Germany
- Study Comparing FOLFOX Before Surgery to Risk-Adapted Chemotherapy After Surgery for Patients with Locally Advanced Rectal Cancer and Low Risk of Local Failure
- Study on the Effectiveness of Autogene Cevumeran in Patients with ctDNA Positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
- Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy
- Study Comparing Short Course Radiotherapy and Chemoradiotherapy with Fluorouracil, Calcium Folinate, and Capecitabine for Intermediate and High-Risk Rectal Cancer Patients
- Study on Organ Preservation in Advanced Rectal Cancer Using Oxaliplatin, Fluorouracil, and Calcium Folinate for Patients with Confirmed Rectal Cancer
- Ireland
- Italy
- Study of Valproic Acid, Capecitabine, and Radiotherapy for Patients with Low-Moderate Risk Rectal Cancer
- Study on Aspirin and Metformin for Patients with Locally Advanced Rectal Cancer
- Study of XELOX chemotherapy with or without dostarlimab after chemoradiation in patients with locally advanced rectal cancer
- Study on Organ Preservation in Advanced Rectal Cancer Patients Using Bleomycin and Electrochemotherapy After Initial Treatment
- Study on Capecitabine and Oxaliplatin for Patients with High Risk Rectal Cancer
- Study on Valproic Acid with Bevacizumab and Oxaliplatin/Fluoropyrimidine for Patients with RAS-Mutated Metastatic Colorectal Cancer
- Netherlands
- Evaluating SGM-101 (fluorochrome-labeled antibody) in patients with locally advanced or recurrent rectal cancer undergoing surgery
- Study of SGM-101 Fluorescent Imaging for Detection of Early Rectal Cancer in Patients with Suspected T1 Adenocarcinoma or High-Grade Dysplasia
- Study on Gallium (68Ga) Chloride PET/CT for Detecting Lymph Node Metastasis in Patients with Early Rectal Cancer
- Study on Preserving the Rectum in Early-Stage Rectal Cancer Patients Using Oxaliplatin and Capecitabine with Radiation Therapy
- Study of drug combination (capecitabine, fluorouracil, oxaliplatin, calcium folinate) to prevent cancer recurrence in patients with detectable ctDNA after rectal cancer surgery
- Study Comparing Surgery and Chemoradiotherapy with Capecitabine for Early Rectal Cancer Patients
- Study on Induction Chemotherapy with Irinotecan, Folinic Acid, Fluorouracil, and Oxaliplatin for Patients with High-Risk Locally Advanced Rectal Cancer
- Spain
- Study on the Effects of Imipramine in Patients with Colon, Rectal, or Breast Cancer Over-Expressing Fascin1
- Study on the Effectiveness of Autogene Cevumeran in Patients with ctDNA Positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
- Study of Durvalumab with Drug Combination for Patients with Locally Advanced Rectal Cancer
- Sweden
Evaluating SGM-101 (fluorochrome-labeled antibody) in patients with locally advanced or recurrent rectal cancer undergoing surgery
This trial tests a new imaging method using SGM-101, a specialized solution given through intravenous infusion before surgery. The medication is actually a modified antibody that becomes visible under special lighting during operations.
Main inclusion criteria: Patients must be 18 years or older with locally advanced T3 or T4 cancer, or recurrent disease. The cancer must be scheduled for surgery. Women who can become pregnant and men must use effective birth control during the study and for at least 30 days after the last treatment.
Main exclusion criteria: Age below 18 or above 65 years, presence of cancer that has spread to other body parts, previous major abdominal surgery within the last 6 months, known allergies to the study medication, pregnancy or breastfeeding, severe heart, liver, or kidney disease, history of other cancers in the past 5 years, and weakened immune system.
Trial focus: The study aims to determine if using SGM-101 together with a special camera system can help surgeons better see and remove all cancer tissue during surgery. The medication attaches to specific markers found on cancer cells, making them glow under special lighting. This could potentially help doctors ensure they remove all of the cancer during the operation.
Investigational treatment: SGM-101 is a specialized imaging agent containing antibodies designed to attach to specific markers found on cancer cells. When injected before surgery, it helps surgeons better visualize cancer tissue by making it glow under special fluorescent light.
Study Comparing FOLFOX Before Surgery to Risk-Adapted Chemotherapy After Surgery for Patients with Locally Advanced Rectal Cancer and Low Risk of Local Failure
This trial compares two approaches for treating locally advanced cancer: receiving chemotherapy before surgery versus receiving chemotherapy after surgery. The chemotherapy regimen being tested is called FOLFOX, which includes medications such as Capecitabine, Fluorouracil, Calcium Folinate Pentahydrate, and Oxaliplatin.
Main inclusion criteria: Patients must have confirmed diagnosis of cancer located between 0 to 16 cm from the anal opening. Blood test results must show normal liver and kidney function. Heart rhythm measurements should be within normal limits. Participants must be at least 18 years old with a performance status of 0 or 1, meaning they are fully active or have some restrictions but can perform light work.
Main exclusion criteria: Patients who have had previous surgery that was not complete or successful for the primary tumor, or those who have had cancer return in the same area after previous surgery. Patients who have been diagnosed with a second type of cancer or have cancer that has spread to other parts of the body are also excluded.
Trial focus: The purpose is to determine which treatment approach is more effective in improving disease-free survival, which refers to the length of time patients remain free from cancer after treatment.
Investigational treatment: FOLFOX is a chemotherapy regimen administered intravenously that includes three main drugs: 5-fluorouracil, leucovorin, and oxaliplatin. These medications work together to stop the growth of cancer cells by interfering with their DNA and preventing them from dividing.
Study comparing preoperative drug combination with irinotecan, fluorouracil, calcium folinate and oxaliplatin for patients with locally advanced resectable rectal cancer
This trial compares two different treatment approaches: using chemotherapy alone versus using chemotherapy followed by combined chemotherapy and radiation therapy before surgery. The treatment involves several medications given through intravenous infusion, including irinotecan hydrochloride, calcium folinate, fluorouracil, and oxaliplatin.
Main inclusion criteria: Patients must have confirmed cancer located in the middle or lower part of the rectum, within 12 cm from the anal opening. The cancer staging must be either T3N0 or T1-T3N+. Age must be 18 or older with a performance status of 0 or 1. Patients must agree to use effective birth control during treatment and for 6 months after the last treatment if able to have children.
Main exclusion criteria: Previous treatment with chemotherapy or radiation therapy, presence of distant cancer spread to other body parts, pregnancy or breastfeeding, severe heart, kidney, or liver disease, active infections, known allergies to study medications, other active cancers within the past 5 years, and major surgery within 4 weeks before starting the study.
Trial focus: The study will help determine if chemotherapy alone can be as effective as the combination of chemotherapy and radiation therapy in treating this type of cancer.
Investigational treatment: The trial uses chemotherapy alone or combined with chemoradiotherapy. Chemotherapy uses powerful medications to kill cancer cells throughout the body, while chemoradiotherapy combines chemotherapy medications with radiation treatment to make cancer cells more sensitive to radiation.
Study of Dostarlimab Combined with Short Course Radiotherapy for Locally Advanced Rectal Cancer Patients with Microsatellite Instability
This study evaluates a treatment approach combining dostarlimab, given through intravenous infusion, with a short course of radiotherapy for patients with cancer that has specific genetic characteristics – microsatellite unstable or mismatch repair-deficient.
Main inclusion criteria: Must be at least 18 years old with confirmed cancer having specific genetic characteristics verified through special laboratory tests. Cancer must be located in the middle or lower part of the rectum and be in stage II or III. Must be able to perform normal daily activities with minimal or no assistance. Must have adequate liver, blood, and kidney function. Women who can become pregnant and men with partners who can become pregnant must use contraception during treatment and for 4 months after treatment ends.
Main exclusion criteria: Age below 18 years old, previous treatments for the cancer including surgery, radiation therapy, or chemotherapy, presence of distant cancer spread, known allergies to study medications, pregnancy or breastfeeding, active or untreated infections, significant heart, liver, or kidney problems, participation in other clinical trials within the past 30 days, and history of other cancers within the past 5 years.
Trial focus: The main purpose is to determine how effective this combination treatment is in controlling the cancer without the need for surgery. The study will monitor if cancer completely disappears after treatment, which would allow patients to avoid surgery.
Investigational treatment: Dostarlimab is an immunotherapy medication that helps the immune system fight cancer cells by blocking a protein called PD-1. Radiotherapy uses high-energy radiation beams to target and destroy cancer cells, given as a short course of treatment to the tumor area.
Study of SGM-101 Fluorescent Imaging for Detection of Early Rectal Cancer in Patients with Suspected T1 Adenocarcinoma or High-Grade Dysplasia
This study uses SGM-101, a fluorescent substance given through intravenous infusion, to help doctors better see the difference between normal tissue and potentially cancerous areas during examination procedures in patients with early cancer.
Main inclusion criteria: Patient must have suspected early cancer and be scheduled for a local endoscopic removal procedure. The affected area must be in the rectum between the boundary of the anal canal and 10 centimeters above the anus. Must be over 18 years old, able to understand and willing to sign an informed consent form, and capable of understanding and following study procedures.
Main exclusion criteria: Known allergies to fluorescent dyes, previous radiation therapy to the pelvic area, pregnancy or breastfeeding, active inflammatory bowel disease, previous major abdominal surgery within the last 6 months, presence of other types of active cancer, severe heart, kidney, or liver problems, weakened immune system, and participation in other clinical trials within the past 30 days.
Trial focus: The purpose is to determine if this fluorescent imaging technique can effectively distinguish between normal tissue and areas with different levels of cell abnormalities in the rectum.
Investigational treatment: SGM-101 is an investigational fluorescent tracer designed to help doctors better identify and distinguish between different types of tissue during endoscopic procedures. When used with a special imaging device, this tracer binds to specific targets in cancerous or pre-cancerous tissue, making them glow and easier to detect.
Study of Valproic Acid, Capecitabine, and Radiotherapy for Patients with Low-Moderate Risk Rectal Cancer
This trial investigates the use of two medications, capecitabine (taken orally) and valproic acid (commonly used as an anticonvulsant), in combination with short-course radiotherapy as preoperative treatment to shrink tumors before surgery.
Main inclusion criteria: Patients must have a confirmed diagnosis of cancer at specific stages located less than 2 cm from the anal opening or between 5-12 cm from the opening. Must be between 18 and 75 years old with a performance status of 0 or 1, meaning they are fully active or have some symptoms but can still do light work. Must use effective birth control if there is a chance of pregnancy and sign a written informed consent form.
Main exclusion criteria: Patients with a different type of cancer other than low-risk disease, those not within the specified age range, unable to give informed consent or understand study requirements, those with other serious health conditions that might interfere, pregnant or breastfeeding women, currently participating in another clinical trial, previous treatment that might affect study results, allergies to study medications, or history of substance abuse.
Trial focus: The study explores whether adding valproic acid or capecitabine to short-course radiotherapy can improve the rate of complete tumor regression before surgery. The first phase aims to determine the maximum safe dose, while the second phase compares the effects of adding these medications.
Investigational treatment: Valproic acid is being tested to see if it can help improve the effectiveness of short-course radiotherapy. Capecitabine is being used to determine if it can enhance the effects of radiotherapy to achieve a higher rate of complete tumor regression before surgery.
Study on Aspirin and Metformin for Patients with Locally Advanced Rectal Cancer
This trial explores the effects of using aspirin, metformin, or both, in combination with standard treatments including chemotherapy and chemoradiotherapy for locally advanced stage II/III disease.
Main inclusion criteria: The patient must have confirmed diagnosis through a biopsy. The tumor must be resectable and eligible for surgery, induction chemotherapy, chemoradiotherapy, and total mesorectal excision. Must be between 18 and 64 years of age. Both male and female patients are eligible.
Main exclusion criteria: Patients with any other type of cancer besides locally advanced stage II/III disease, not in the specified age range, not able to understand or follow study procedures, pregnant or breastfeeding, certain medical conditions that might interfere with study treatments, currently participating in another clinical trial, recent major surgery or planned surgery during the study period, or known allergies to study medications.
Trial focus: The purpose is to assess how well these treatments work in shrinking the tumor before surgery. The study will help determine if adding these medications can improve the response of the tumor to treatment.
Investigational treatment: Aspirin is being tested to see if it can help improve the effectiveness of chemotherapy and radiation therapy. Metformin is being evaluated for its potential to enhance the response to chemotherapy and radiation therapy before surgery.
Study on Early Erectile Rehabilitation with Sildenafil for Men After Rectal Cancer Surgery
This trial investigates the use of Sildenafil, commonly known for treating erectile dysfunction, to see if taking it early after surgery can help prevent long-term erectile dysfunction in men who have undergone surgery for the disease.
Main inclusion criteria: Men aged 18 to 70 years who had surgery for cancer in the lower or middle part of the rectum about 30 days ago and had normal erectile function before surgery. Must be sexually active and have a stable sexual partner. Men must agree to use a condom, be vasectomized, or practice sexual abstinence to prevent pregnancy and drug exposure to a partner.
Main exclusion criteria: Women cannot participate. Men who have not undergone surgery for the disease or are not within the specified age range cannot participate. Individuals who belong to a vulnerable population also cannot participate.
Trial focus: The main goal is to see if Sildenafil can help maintain normal erectile function one year after surgery.
Investigational treatment: Sildenafil is being tested to help with erectile rehabilitation and prevent long-term erectile dysfunction after surgery. It is taken orally and works by blocking an enzyme called phosphodiesterase type 5, which results in increased blood flow to help achieve and maintain an erection.
Study on Gallium (68Ga) Chloride PET/CT for Detecting Lymph Node Metastasis in Patients with Early Rectal Cancer
This trial investigates a new imaging method using a special solution called [68Ga]Ga-FAPI-46 in a type of scan known as positron emission tomography or PET/CT, which helps doctors see if cancer has spread to nearby lymph nodes.
Main inclusion criteria: Patients must be at least 18 years old with suspected or confirmed early cancer. For Group A: must have specific staging without signs of cancer spreading to other parts of the body and be scheduled for primary surgery. For Group B: must have tumors suitable for local removal with specific features seen during endoscopy.
Main exclusion criteria: Patients who are not diagnosed with the disease, not within the specified age range, or part of a vulnerable population cannot participate.
Trial focus: The purpose is to determine how accurately the [68Ga]Ga-FAPI-46 PET/CT scan can detect cancer spread compared to the results from surgery.
Investigational treatment: [68Ga]Ga-FAPI-46 is a special imaging agent used in PET/CT scans that helps doctors see if there are any cancerous lymph nodes. It works by highlighting areas in the body where cancer cells might be present, allowing for more accurate detection.
Study on Managing Locally-Advanced Rectal Cancer with Oxaliplatin, Fluorouracil, and Irinotecan Hydrochloride for Patients Responding Well to Initial Chemotherapy
This trial evaluates a personalized approach to managing disease after a positive response to initial chemotherapy. The treatment involves several medications including Oxaliplatin, Fluorouracil, Irinotecan Hydrochloride, Capecitabine, and Calcium Folinate.
Main inclusion criteria: The patient must have the disease with specific characteristics including tumor shrinkage of 60% or more and adequate margins. There should be no clear signs of cancer spread to other parts of the body on CT scan. Patient should be in good enough health for major surgery and treatment with Capecitabine. Must have normal blood, liver, kidney, and electrolyte functions.
Main exclusion criteria: Patients who have not responded well to initial treatment, cannot achieve a satisfactory surgical outcome where all visible cancer is removed, are not within the specified age range, or are part of a vulnerable population.
Trial focus: The study is focused on maintaining a satisfactory surgical outcome while minimizing treatment intensity in two phases. The first phase ensures high success rate for surgical removal, while the second phase aims to maintain the rate of patients remaining free from cancer for three years.
Investigational treatment: Induction chemotherapy is a treatment given to shrink a tumor before the main treatment, which is usually surgery. It is being tested to see if patients respond well to the chemotherapy before considering other treatment options.
Summary
The 32 ongoing clinical trials for rectal cancer reflect a diverse research landscape exploring multiple treatment approaches. A notable concentration of studies is being conducted in European countries, particularly in France, the Netherlands, Germany, and Italy, with these four countries hosting the majority of trials.
Several prominent research themes emerge from these trials. Imaging innovation is a significant focus, with studies testing fluorescent imaging agents like SGM-101 and novel contrast agents such as Ferumoxtran-10 to improve surgical precision and staging accuracy. Immunotherapy represents another key area, with multiple trials investigating immune checkpoint inhibitors including dostarlimab, durvalumab, and atezolizumab, often in combination with chemotherapy or radiation.
Organ preservation strategies appear frequently across the trials, with researchers exploring whether less invasive approaches can achieve outcomes comparable to traditional surgery. Many studies are testing combinations of chemotherapy regimens like FOLFOX, FOLFOXIRI, and XELOX in various sequences with radiation therapy to maximize tumor response while potentially avoiding or delaying surgery.
The trials also address specific patient populations, including those with particular genetic markers such as MSI-high/MMR-deficient tumors, RAS mutations, and BRAF V600E mutations, reflecting the growing trend toward precision medicine in cancer treatment. Several studies focus on quality of life outcomes, including investigations into erectile dysfunction prevention after surgery and the effects of aspirin on cancer recurrence across multiple cancer types.
The research spans the full spectrum of disease stages, from early-stage disease where organ preservation may be possible to locally advanced and metastatic cases requiring more intensive multimodal approaches. This comprehensive research effort aims to improve both survival outcomes and quality of life for patients with rectal cancer through personalized treatment strategies.
