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

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 89

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the present study is to estimate the clinical complete response rate after anintensified radiochemotherapy regimen in locally advanced rectal cancer. This clinical completeresponse determined in this study will be the basis for a consecutive study using the sameradiochemotherapy regimen with 2-year local control as endpoint.		The primary objective of the present study is to estimate the clinical complete response rate after anintensified radiochemotherapy regimen in locally advanced rectal cancer. This clinical completeresponse determined in this study will be the basis for a consecutive study using the sameradiochemotherapy regimen with 2-year local control as endpoint.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Universitaetsklinikum Tuebingen AöR
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Tuebingen, Germany
Universitaetsklinikum Wuerzburg AöR
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Wuerzburg, Germany
Universitaetsklinikum Erlangen AöR
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Erlangen, Germany
Goethe University Frankfurt
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Frankfurt Am Main, Germany
Universitaetsklinikum Tuebingen AöR
🇩🇪Tuebingen, Germany
Cihan Gani
Site contact
+4970712982165
cihan.gani@med.uni-tuebingen.de

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