Study Comparing Short Course Radiotherapy and Chemoradiotherapy with Fluorouracil, Calcium Folinate, and Capecitabine for Intermediate and High-Risk Rectal Cancer Patients

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What is this study about?

This clinical trial is focused on studying treatments for intermediate and high-risk rectal cancer. The study compares two different approaches: short course radiotherapy and chemoradiotherapy, both followed by additional chemotherapy. The goal is to explore the possibility of preserving the rectum without major surgery or the need for a stoma, which is an opening created in the abdomen to allow waste to leave the body. The trial involves several medications, including Fluorouracil, Calcium Folinate Pentahydrate, Capecitabine, and Oxaliplatin. These medications are used in different forms, such as injections and tablets, to help treat the cancer.

The purpose of the study is to determine if these treatments can improve the rate of organ preservation, meaning the rectum remains intact without the need for major surgery. Participants will receive either the short course radiotherapy or chemoradiotherapy, followed by consolidation chemotherapy, which is additional treatment to help strengthen the effects of the initial therapy. The study will monitor the participants over a period to assess the effectiveness of the treatments in preserving the rectum and improving survival rates.

Throughout the study, participants will undergo various procedures, including MRI scans, to evaluate the progress of the treatment. The trial aims to improve the 3-year organ preservation rate from 30% to 40% in patients receiving the investigational treatment. This research is part of a larger effort by the German Rectal Cancer Study Group to find better ways to treat rectal cancer while minimizing the need for invasive surgeries.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of intermediate or high-risk rectal cancer.

Initial assessments include MRI and possibly endoscopic ultrasound to determine the extent of the cancer.

2 treatment phase 1: radiotherapy or chemoradiotherapy

Participants receive either short course radiotherapy or chemoradiotherapy. The choice depends on the specific characteristics of the cancer as determined by MRI.

This phase aims to reduce the size of the tumor and prepare for further treatment.

3 treatment phase 2: consolidation chemotherapy

Following the initial treatment, consolidation chemotherapy is administered.

Medications include fluorouracil and calcium folinate pentahydrate, both given as solutions for injection through intravenous use.

Additional medication, capecitabine, is provided in the form of film-coated tablets for oral use.

Another medication, oxaliplatin, is administered as a solution for infusion intravenously.

4 monitoring and assessment

Regular monitoring occurs to assess the response to treatment. This includes imaging studies and clinical evaluations.

The goal is to determine if the cancer has responded sufficiently to avoid major surgery.

5 decision on organ preservation

Based on the response to treatment, a decision is made regarding organ preservation.

The primary aim is to maintain the rectum intact without major surgery or the need for a stoma.

6 follow-up and long-term monitoring

Participants are followed up regularly to monitor for any signs of cancer recurrence or complications.

The study aims to improve the rate of organ preservation and assess long-term outcomes such as survival and quality of life.

Who Can Join the Study?

  • Both men and women can participate.
  • Must have a confirmed diagnosis of rectal adenocarcinoma, which is a type of cancer in the rectum, located 0 to 12 cm from the anocutaneous line (the area where the anus meets the skin) as measured by a special procedure called rigid rectoscopy.
  • Must undergo a special imaging test called high-resolution MRI of the pelvis to check the local area of the cancer.
  • The MRI must show at least one high-risk condition, such as:
    • Any cT3 tumor if it is less than 6 cm from the anocutaneous line.
    • cT3c/d tumor in the middle third of the rectum (6-12 cm) with evidence of the tumor spreading more than 5 mm into the surrounding fat.
    • cT3 tumor with clear signs of cancer in nearby lymph nodes.
    • cT4 tumors or any tumor in the middle/low third of the rectum with clear signs of cancer in nearby lymph nodes or close to important structures.
    • Signs of cancer spreading into nearby veins, known as extramural venous invasion (EMVI+).
  • If the MRI is not clear, a transrectal endoscopic ultrasound (EUS) may be used to rule out early-stage tumors.
  • A spiral-CT scan of the abdomen and chest is needed to ensure the cancer has not spread to distant parts of the body.
  • Participants must be at least 18 years old, with no upper age limit.
  • Must have a WHO/ECOG Performance Status of 0 or 1, which means the person is fully active or has some symptoms but can still carry out light work.
  • Must have adequate blood, liver, kidney, and metabolic function, with specific requirements for blood cell counts and other lab values.
  • Must provide informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients who have had any major surgery other than a small, local removal of tissue after joining the study.
  • Patients who have experienced any growth of cancer in the local area that cannot be removed with surgery.
  • Patients who need a stoma, which is an opening made in the body to help with waste removal, due to treatment side effects or poor function.
  • Patients who are not able to have a stoma removed within 6 months after finishing treatment.
  • Patients who have experienced any growth of cancer in the local area that requires a major surgery to remove it.
  • Patients who have passed away during the study period.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
St. Vincenz-Krankenhaus GmbH Paderborn Germany
Kliniken Maria Hilf GmbH Moenchengladbach Moenchengladbach Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Katholisches Klinikum Bochum gGmbH Bochum Germany
Klinikum St Marien Amberg Amberg Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Klinikum Bielefeld gGmbH Bielefeld Germany
Lahn-Dill-Kliniken GmbH Wetzlar Germany
Krankenhaus Maria Hilf GmbH Krefeld Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Pi.Tri Studien GmbH Offenburg Germany
Sana Klinikum Offenbach GmbH Offenbach Am Main Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Mutlangen Germany
Diakonie Klinikum Dietrich Bonhoeffer GmbH Neubrandenburg Germany
MVM Medizinische Verwaltungs und Managementgesellschaft mbH Leer (ostfriesland) Germany
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Klinikum St. Georg gGmbH Leipzig Germany
Philipps-Universitaet Marburg Marburg Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Muenchen Klinik gGmbH Munich Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Germany
MVZ Nordoberpfalz GmbH Weiden I.D.Opf. Germany
Universitaetsklinikum Leipzig AöR Leipzig Germany
St. Bernward Krankenhaus GmbH Hildesheim Germany
Onkologisches Ambulanzzentrum Hanover Germany
Ugvypbfjfijidjagerzvi Kvctdlhxkyamyuaunvktyks Bbwnnc Gfcl Bochum Germany
Uvvvnqcjkpdvihapdwnww Eaikq Aku Essen Germany
Eexwmbosiiabp Wgzcpqlftgxjnjx Sslband Kivxvfpqrjoquitujrg gajmz Berlin Germany
Skwexhvlybstlbjhp Psyezesu gsnop Recklinghausen Germany
Ohvavzvjfjhl Sclfgqktypobbsqjc id Mqrmoyqgb Hildesheim Germany
Phhqaz fxo Sjljqrofgjvihhtv Djr mjwb Ay Sgcamoixq Dresden Germany
Pbmrxt fyn Hekdgwithjx uxb Oivrleeeo Giessen Germany
ddjpgsauahrcywbjjvzjlmyxpfix Guwfvekpwgikcbqiptx Coburg Germany
Oicvdicybqlo Sbpgzaapqukeebqaj Dulkwgify Darmstadt Germany
Egnkozfhrxazo Kcthjfoiqce Wncth Gyay Wesel Germany
Kwxlnjhu Fgqnl gyi Fulda Germany
Kdlnzgbm Ruheuy Rheine Germany
Phnfxcyk Wjiueobun Wolfsburg Germany
Gpewvv Uscehrtbem Fabvsxuom Frankfurt Germany
Kwqoacuv Bxolwrtl Grae Bayreuth Germany
Uyycrcpecjtpeednyqdoy Wrrgctyik Alj Wuerzburg Germany
Kcygaihk Eclixqhxqlzkgohkdgrgsjwa Hoiiublwiqtweldjx Essen Germany
Kouuklfu Lcpez Gnsw Detmold Germany
mnbybf Kwskgqdr ghwfm Ostfildern Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.07.2020

Trial locations

Short Course Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells in the rectum. This therapy is given over a short period and aims to shrink the tumor before any further treatment.

Chemoradiotherapy combines chemotherapy and radiotherapy. Chemotherapy uses drugs to destroy cancer cells, while radiotherapy uses high-energy rays. Together, they work to make the cancer cells more sensitive to the radiation, enhancing the treatment’s effectiveness.

Consolidation Chemotherapy involves using chemotherapy drugs after initial treatments to further reduce the number of cancer cells. This step aims to consolidate the gains made by the previous treatments and help prevent the cancer from returning.

Selective Organ Preservation is a strategy to avoid major surgery and maintain the function of the rectum. This approach focuses on preserving the organ by using less invasive treatments, allowing patients to keep their rectum intact if the cancer responds well to the initial therapies.

Investigated diseases:

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It often starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. The disease is categorized into different stages based on how far it has spread, with intermediate and high-risk stages indicating more advanced progression. As the cancer grows, it can invade nearby tissues and organs, potentially leading to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can also involve the spread to lymph nodes and other parts of the body, known as metastasis. Early detection and monitoring are crucial for managing the disease and preventing further complications.

Trial ID:
2024-511577-29-01
Protocol code:
ACO/ARO/AIO-18.1
NCT ID:
NCT04246684
Trial Phase:
Therapeutic confirmatory (Phase III)

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