Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy. A prospective phase II pilot trial of the German Rectal Cancer Study Group

Trial details

Who runs it

Universitaetsklinikum Tuebingen AöR

Trial code

EU 2024-517928-19-00

Record updated

25 February 2025

Original description

estimate the effect of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancerRead full original descriptionShow less

estimate the effect of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer

Inclusion: Male and female patients with histologically confirmed diagnosis of rectalcancer localized 0 – 12 cm from the anocutaneous line as measured byrigid rectoscopy (i.e. lower and middle third of the rectum) Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal stagingaccording to “SOP MRI” Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magneticresonance imaging (MRI) of the pelvis is the mandatory local stagingprocedure. Cross-sectional imaging of the abdomen and chest to exclude distantmetastases. Aged at least 18 years. No upper age limit. WHO/ECOG Performance Status ≤ 1 Adequate hematological, hepatic, renal and metabolic function parameters:o Leukocytes ≥ 3.000/mm^3o ANC ≥ 2.000/mm^3o Platelets ≥ 100.000/mm^3 Hb > 9 g/dlo Serum creatinine ≤ 1.5 x upper limit of normalo Creatinin-Clearance ≥ 30 ml / mino Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit ofnormalo Informed consent of the patient Informed consent of the patient.

Exclusion: Lower border of the tumor localised more than 12 cm from theanocutaneous line as measured by rigid rectoscopy cT4 tumors Positive lateral pelvic lymph nodes (s. SOP MRI) Distant metastases (to be excluded by CT scan of the thorax andabdomen) Preexisting fecal incontince for solid stool Preexisting peripheral sensory neuropathy with functional impairment Preexisting myelosuppression refleted by a neutrophil count < 2.000/mm^3and/or platelets < 100.000/mm^3 Severe impairment of kidney function with a Creatinin Clearance < 30ml/min) Prior antineoplastic therapy for rectal cancer Prior radiotherapy of the pelvic region Major surgery within the last 4 weeks prior to inclusion Subject pregnant or breast feeding, or planning to become pregnant within6 months after the end of treatment. Subject (male or female) is not willing to use highly effective methods ofcontraception according to the “Clinical trial fertility group”recommendations(http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment and for 6 months (male or female) after the end oftreatment (adequate: combined hormonal contraception associated withinhibition of ovulation, progestogen-only hormonal contraceptionassociated with inhibition of ovulation, intrauterine device, intrauterinehormone-releasoing system, bilateral tubal occlusion, vasectomizedpartner1, sexual abstinence2). On-treatment participation in an interventional clinical study in the period 30days prior to inclusion Previous or current drug abuse Other concomitant antineoplastic therapy Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections,active, disseminated coagulation disorder, severe liver function disorders WHO/ECOG Performance Status > 1 Clinically significant cardiovascular disease (incl. myocardial infarction,unstable angina, symptomatic congestive heart failure, serious uncontrolledcardiac arrhythmia) ≤ 6 months before enrolment. Chronic diarrhea (> grade 1 according NCI CTCAE) Prior or concurrent malignancy ≤ 3 years prior to enrolment in study(Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage0-1), if the patient is continuously disease-free Known allergic reactions on study medication Known dihydropyrimidine dehydrogenase deficiency Medication inhibitors of the dihydropyrimidine dehydrogenase, such asBrivudin, Sorivudin and its analogues. Pernicious anemia or other anemias caused by Vitamin B-12 deficiency. Psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule(these conditions should be discussed with the patient before registration inthe trial). Additionally for hyperthermia cardiac pacemakers and metal implants in theproximity of the pelvis constitute a criterion for exclusion.

EU CTIS 2024-517928-19-00