Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolitadion chemotherapy. A prospective Phase II Pilot Trial of the German Rectal Cancer Group CAO/ARO/AIO-16
Study type:Investigator-driven, multicenter, open, prospective phase II study
Population: Patientens with local advanced rectal cancer cUICC (Phase II-III)
Primary objective:The primary objective of the study is to estimate the effect of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As primary endpoint, the rate of patients with a clinical complete response (cCR) will be determined. This rate will then be the basis for patient number calculations in a consecutive trial with 3-year loco-regional control as endpoint.
- Local regrowth rat
- Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0)
- Fecal incontinence according to Wexner-Vaizey Score
- Quality of life according to EORTC QOL-C30 and QOL-CR29
- Frequency of Low anterior resection syndrome (LARS-scale)
- Surgical morbidity and complications in patients undergoing surgery
- Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery
- R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery
- Rate of sphincter-sparing surgery in patients undergoing surgery
- Relapse-free survival (local / distant / overall)
- Overall survival
- Translational biomarker studies
- Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0 – 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
- Any MRI staged cT3 tumor or any cT1 cN+ or cT2 cN+ with nodal staging according to “SOP MRI”
- Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit.
- WHO/ECOG Performance Status ≤ 1
- Informed consent of the patient
- Adequate hematological, hepatic, renal and metabolic function parameters:
- Leukocytes ≥ 3.000/mm^3
- ANC ≥ 1.500/mm^3
- Platelets ≥ 100.000/mm^3
- Hb > 9 g/dl
- Serum creatinine ≤ 1.5 x upper limit of normal
- Creatinin-Clearance ≥ 30 ml / min
- Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of norm