Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy. (CAO/ARO/AIO-16)
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|ClinicalTrials.gov Identifier: NCT03561142|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer Rectal Neoplasms Rectal Cancer Stage II Rectal Cancer Stage III||Radiation: Radiotherapy Drug: Chemotherapy Other: Deep regional hyperthermia||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Patients will undergo different treatments based on response achieved after radiochemotherapy.
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||April 16, 2020|
|Estimated Study Completion Date :||April 16, 2024|
Experimental: Radiochemotherapy -> chemotherapy.
Radiochemotherapy followed by consolidation chemotherapy. Deep regional hyperthermia can additionally be performed at the centers in Tübingen and Erlangen.
Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38
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
Other Name: all brands of the used drugs are allowed
Other: 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.
- 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
- Local regrowth rate [ Time Frame: 4 years ]
- Safety of the treatment (toxicity assessment according to NCI CTCAE Version 4.0) [ Time Frame: 4 years ]
- Fecal incontinence according to Wexner-Vaizey Score [ Time Frame: 4 years ]Possible scores range from 0 (perfect continence) to 24 (complete incontinence)
- Quality of life according to EORTC Quality of Life questionnaire - C30 [ Time Frame: 4 years ]
- Quality of life according to EORTC Quality of Life questionnaire - CR29 [ Time Frame: 4 years ]
- Frequency of Low anterior resection syndrome (LARS-scale) [ Time Frame: 4 years ]
- Surgical morbidity in patients undergoing surgery [ Time Frame: up to 30 days after surgery ]
- Surgical complications in patients undergoing surgery [ Time Frame: up to 30 days after 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 [ Time Frame: Day 123 after the start of treatment ]
- R0 resection rate, rate of circumferential resection margin negativity (> 1mm) in patients undergoing surgery [ Time Frame: Day 123 after the start of treatment ]
- Rate of sphincter-sparing surgery in patients undergoing surgery [ Time Frame: Day 123 after the start of treatment ]
- Relapse-free survival (local / distant / overall) [ Time Frame: 4 years ]
- Overall survival [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561142
|Contact: Cihan Gani, Dr.||+firstname.lastname@example.org|
|Contact: Daniel Zips, Prof.||+email@example.com|
|University Hospital Erlangen||Not yet recruiting|
|Contact: Oliver Ott, Prof.|
|University Hospital Frankfurt||Not yet recruiting|
|Contact: Claus Rödel, Prof.|
|University Hospital Tübingen||Recruiting|
|Contact: Cihan Gani, Dr.|
|University Hospital Würzburg||Not yet recruiting|
|Contact: Bülent Polat, Dr.|
|Principal Investigator:||Cihan Gani, Dr.||University Hospital Tübingen|