1. Clinical complete response rate (Time Frame - Day 106 after the start of treatment): Response to treatment is assessed on day 106 after the start of radiochemotherapy.
A clinical complete response is defined by standardized findings in rectoscopy, MRI and digital rectal examination
Secondary outcome:
1. Local regrowth rate (Time Frame - 4 years)
2. Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0) (Time Frame - 4 years)
3. Fecal incontinence according to Wexner-Vaizey Score (Time Frame - 4 years): Possible scores range from 0 (perfect continence) to 24 (complete incontinence)
4. Quality of life according to EORTC Quality of Life questionnaire - C30 (Time Frame - 4 years)
5. Quality of life according to EORTC Quality of Life questionnaire - CR29 (Time Frame - 4 years)
6. Frequency of Low anterior resection syndrome (LARS-scale) (Time Frame - 4 years)
7. Surgical morbidity in patients undergoing surgery (Time Frame - up to 30 days after surgery)
8. Surgical complications in patients undergoing surgery (Time Frame - up to 30 days after surgery)
9. Pathological staging, tumor downstaging (assessed by ypTNM findings in relation to initial cTNM staging), tumor regression grading according to Dworak in patients undergoing surgery (Time Frame - Day 123 after the start of treatment)
10. R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery (Time Frame - Day 123 after the start of treatment)
11. Rate of sphincter-sparing surgery in patients undergoing surgery (Time Frame - Day 123 after the start of treatment)
Radiotherapy: Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38
Chemotherapy (all brands of the used drugs are allowed): chemoradiotherapy is started according to the following schedule: 5-FU: 250 mg/sqm per day, iv, on day 1-14, day 22-35; Oxaliplatin: 50 mg/sqm, day 1, 8, 22, and 29. After a break of two and a half weeks, patients receive three chemotherapy cycles, starting on day 57, 71 and 85, consisting of: Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv
Deep regional hyperthermia: Deep regional hyperthermia to the pelvis, total time 90 min, target temperature 41-42°C. Twice weekly, up to a total of 10 sessions within d1 and d38.
Deep regional hyperthermia is offered at the centers in Tübingen and Erlangen.
Quelle: ClinicalTrials.gov
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"Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy."
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