In short
There are currently 2 ongoing clinical trials investigating new treatment approaches for rectal adenocarcinoma. These studies are exploring advanced therapies that aim to preserve the rectum and improve survival rates through combinations of chemotherapy, radiation, and targeted treatments. Trials are being conducted in France and Italy, offering patients new options for managing this disease.
Clinical trial locations
- France
- Italy
Study on Contact X-ray Brachytherapy with Capecitabine for Rectal Cancer Preservation in Adults with Intermediate Stage Rectal Adenocarcinoma
This trial is investigating a specialized radiation treatment called contact X-ray brachytherapy combined with comprehensive pre-surgery therapy for patients with intermediate-stage rectal cancer. The main goal is to preserve the rectum while improving survival rates.
Main inclusion criteria:
- Confirmed diagnosis of rectal adenocarcinoma with intermediate risk factors (tumor size between 3.1 cm and 6 cm)
- Specific cancer stages: cT2N1 or T3N0-1, M0
- Tumor must be reachable by digital rectal exam and located in the lower or middle part of the rectum
- At least 18 years old with WHO status of 0 or 1
- Adequate blood counts and organ function, including liver, kidney, and bone marrow
- Women of childbearing potential must have negative pregnancy test and agree to use effective birth control for at least 6 months after treatment, extending to 9 months after oxaliplatin
- Male patients must agree to use condoms during treatment and for 6 months afterward
Main exclusion criteria:
- Different type of cancer than the one being studied
- Cancer that has spread to other parts of the body (metastasis)
- Previous treatments that might interfere with the study
- Other serious health conditions affecting participation
- Pregnancy or breastfeeding
- Unable to follow study procedures
Focus and investigational treatments:
The trial uses a comprehensive approach called total neoadjuvant therapy (TNT), which combines several treatments before any potential surgery. Patients first receive mFolfirinox chemotherapy, which includes capecitabine taken as tablets, along with oxaliplatin, irinotecan, folinic acid, and fluorouracil given through infusions. This chemotherapy is given for up to four cycles.
Following chemotherapy, patients receive contact X-ray brachytherapy, a targeted radiation treatment that delivers high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissue. This radiation therapy works by damaging the DNA of cancer cells, leading to their death and preventing tumor growth. Throughout the trial, which is expected to continue until May 2030, patients are closely monitored to assess how well the rectum functions, quality of life, survival rates, and any potential complications.
Study on Oxaliplatin and Capecitabine for Patients with Locally Advanced Rectal Cancer
This Italian trial is studying a non-surgical treatment approach for locally advanced rectal cancer using a combination of chemotherapy and radiation therapy. The study aims to determine if this approach can effectively prevent cancer from returning without the need for surgery.
Main inclusion criteria:
- Confirmed diagnosis of adenocarcinoma of the medium or lower rectum
- Stage II (cT3-4 N0) or Stage III (cT1-4, N1-2) tumor that is locally advanced
- Cancer suitable for Total Mesorectal Excision or Abdominal-Perineal Amputation surgery
- No signs of cancer spread to other body parts, confirmed by scans
- Older than 18 years with ECOG performance status of 0-1
- Adequate blood counts: white blood cells greater than 1.5 cells/mm3, hemoglobin greater than 8.0 g/dL, platelets greater than 150,000/mm3
- Adequate liver and kidney function
- No previous radiation therapy to the pelvic area or previous cancer treatments
- Women of childbearing potential must have negative pregnancy test and use effective birth control
- Men must also use effective birth control methods
Main exclusion criteria:
- Different type of cancer than the one being studied
- Cancer not in the specified stages (Stage II or Stage III)
- Unable to undergo the specific treatments being studied
- Cannot commit to intensive follow-up schedule
- Part of a vulnerable population requiring special protection or care
Focus and investigational treatments:
The study uses a structured treatment approach starting with induction chemotherapy using oxaliplatin given through infusion to shrink the tumor. This is followed by chemo-radiotherapy, which combines chemotherapy drugs with radiation therapy. The chemotherapy makes cancer cells more sensitive to radiation, helping to destroy the tumor more effectively.
After these initial treatments, patients enter a phase called non-operative management, where surgery is avoided if the tumor shows complete response. Instead, patients undergo intensive follow-up with regular check-ups, physical exams, imaging tests, and laboratory tests to monitor for any signs of cancer recurrence. The study examines various blood and tissue markers to understand how the treatment affects the cancer and evaluates complete response rates, overall survival, quality of life, and organ preservation.
Summary
These two clinical trials represent important research efforts in treating rectal adenocarcinoma through innovative approaches that aim to preserve the rectum and avoid major surgery when possible. The French trial focuses on intermediate-stage disease using contact X-ray brachytherapy combined with comprehensive chemotherapy, while the Italian trial investigates non-surgical management for locally advanced stages through chemotherapy and radiation combinations.
Both studies share common investigational drugs, particularly oxaliplatin and capecitabine, reflecting the established role of these chemotherapy agents in treating this disease. A notable feature of both trials is their emphasis on organ preservation and quality of life, moving beyond traditional surgical approaches. The trials require careful patient selection with specific tumor characteristics and adequate organ function, and both mandate effective birth control measures due to the potential effects of chemotherapy on reproduction.
Patients interested in these trials should discuss with their healthcare providers whether they meet the eligibility criteria and whether participation might be appropriate for their individual situation.
