Ongoing Clinical Trials for Rectal Cancer Stage II
There are currently 3 ongoing clinical trials investigating new treatment approaches for rectal cancer stage II. These studies are testing combinations of radiotherapy, immunotherapy, targeted therapy, and chemotherapy to improve outcomes for patients. Trials are being conducted in Belgium, Germany, and Austria.
Clinical trial locations
- Austria
- Belgium
- Germany
Study Comparing Short-Course Radiotherapy and Drug Combination for Older Patients with Locally Advanced Rectal Cancer
This trial focuses specifically on older patients aged 70 years or more with locally advanced rectal cancer. The study compares two treatment approaches to determine which offers a better 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 opening. They must have operable stage III or high-risk stage II cancer, meaning the tumor has certain concerning features such as being large, close to important structures, or having spread to nearby veins. Patients need adequate bone marrow, liver, and kidney function, with specific blood count and organ function requirements. Their overall physical condition should allow them to perform daily activities with limited limitations.
Main exclusion criteria: Patients with any other type of cancer, previous treatment for rectal cancer, severe heart problems, uncontrolled high blood pressure, severe liver or kidney disease, or active infections cannot participate. Pregnant or breastfeeding women and those participating in another clinical trial are also excluded.
Focus and goal: The trial compares 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 study aims to provide valuable information on the best treatment strategy for older patients, ultimately helping to improve their quality of life and treatment outcomes. Participants will be followed over time to assess outcomes such as overall survival, progression-free survival, and side effects.
Investigational treatments: The study uses short-course radiotherapy, which delivers high-dose radiation over about one week to shrink tumors before surgery, and total neoadjuvant therapy, a comprehensive approach combining chemotherapy and radiation before surgery. Medications used include Capecitabine, Oxaliplatin, and Fluorouracil for cancer treatment, along with supportive medications such as Ondansetron, Dexamethasone, Folinic Acid, and Metoclopramide to help manage side effects.
Study of Regorafenib and Nivolumab with radiotherapy for patients with stage II-III rectal cancer before surgery
This Belgian trial investigates a novel combination of immunotherapy, targeted therapy, and radiation for patients with stage II-III rectal cancer before surgery. The study specifically focuses on tumors with particular genetic characteristics known as pMMR/MSS.
Main inclusion criteria: Patients must be at least 18 years old with confirmed rectal adenocarcinoma located within 15 cm from the anal opening. They must have good overall physical condition, able to perform daily activities, with a life expectancy of at least 3 months. Adequate kidney, liver, and blood cell counts are required. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 7 months after. Men with partners who can become pregnant must use condoms during the study and for 5 months after.
Main exclusion criteria: Prior cancer treatment for rectal cancer, active or untreated brain metastases, known autoimmune disease, active infections requiring treatment, history of organ transplant, use of immunosuppressive medications within 14 days before starting, uncontrolled high blood pressure, significant heart disease, major surgery within 28 days, active bleeding or high bleeding risk, pregnancy or breastfeeding, and known allergies to study medications all prevent participation.
Focus and goal: The study aims to determine if combining two medications with short-course radiotherapy can achieve a complete response, meaning no signs of cancer remain after treatment. Patients receive treatment both before and after radiotherapy, with regular monitoring through medical examinations and imaging tests throughout the treatment period.
Investigational treatments: Nivolumab is an immunotherapy given through intravenous infusion at a maximum daily dose of 240 mg, working by blocking a protein called PD-1 to help the immune system recognize and destroy cancer cells. Regorafenib is taken as tablets at a maximum daily dose of 60 mg, blocking several proteins that help cancer cells grow and spread. These medications are combined with short-course radiotherapy, which delivers targeted radiation to kill cancer cells over a shorter period than traditional radiotherapy.
Study on Adjuvant Therapy with Capecitabine for Stage II Colon and Rectal Cancer Patients with Positive ctDNA After Tumor Removal
This trial, conducted in Germany and Austria, focuses on additional therapy after surgery for patients with stage II cancer. It uses a blood test to detect circulating tumor DNA to guide treatment decisions.
Main inclusion criteria: Patients must have had surgery to remove stage II colon or rectal cancer. For rectal cancer located in the upper third of the rectum that does not require radiation therapy, it is treated like colon cancer. Patients must sign informed consent to participate in screening and the randomized phase of the study. They must have a known microsatellite or mismatch repair status, which refers to specific characteristics of cancer cells. A confirmed circulating tumor DNA result must be available. The study is open to both male and female patients.
Main exclusion criteria: Patients with medical conditions other than stage II colon or rectal cancer, those not within the specified age range for the study, and those who are part of vulnerable populations cannot participate.
Focus and goal: The study evaluates the effectiveness of additional chemotherapy in patients who have a specific marker in their blood called circulating tumor DNA after surgery. Participants are randomly assigned to receive either chemotherapy with Capecitabine or follow-up without additional therapy. The study monitors how long patients remain free from cancer and explores the relationship between circulating tumor DNA levels and the risk of cancer returning or spreading.
Investigational treatments: Adjuvant therapy with Capecitabine is given after primary surgery to help prevent cancer from returning. The treatment is oral chemotherapy taken according to the study protocol. A circulating tumor DNA test is used through a blood sample to detect small fragments of DNA released by cancer cells, which can indicate the presence of residual disease and help determine who may benefit from additional treatment after surgery.
Summary
The three ongoing clinical trials for rectal cancer stage II demonstrate diverse approaches to improving patient outcomes. Belgium hosts two trials focusing on treatment before surgery, including one specifically for older patients and another combining immunotherapy with targeted therapy. The German-Austrian collaboration takes a different approach by focusing on treatment decisions after surgery based on blood marker analysis.
A notable pattern is the emphasis on personalized medicine, with trials using genetic characteristics of tumors and circulating tumor DNA to guide treatment decisions. The combination of established treatments like radiotherapy and chemotherapy with newer approaches such as immunotherapy reflects the evolving landscape of cancer care. Two trials specifically address underserved populations: older patients and those with stage II disease where treatment decisions can be challenging.
All three studies incorporate modern treatment strategies including short-course radiotherapy, immunotherapy, and precision medicine approaches through biomarker testing. The geographic concentration in Belgium and German-speaking countries suggests strong research infrastructure in these regions for rectal cancer clinical trials.
