Symptoms and General Pathology

Wounds and Injuries

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Hyperthermia

Fever

Pathologic Complete Response

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

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Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week

Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.

Deep regional hyperthermia

Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.

Radiotherapy

5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.

Chemotherapy (5-Fluorouracil)

The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.

Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial

University Hospital Tuebingen

Micronutrients

Hematinics

Vitamins

Leucovorin

Levoleucovorin

Oxaliplatin

Folic Acid

Folinic Acid

Folate

Vitamin B9

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

Chemotherapy

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.

Cihan Gani, Dr.

Daniel Zips, Prof.

Oliver Ott, Prof.

Claus Rödel, Prof.

Bülent Polat, Dr.

There is a growing body of evidence that surgery and associated morbidities can be omitted without compromising oncological safety in selected patients who have achieved a clinical complete response after radiochemotherapy. However with standard neoadjuvant treatment regimens the pathological complete response rate lies in the range between 10%-20%, the number of patients qualifying for non-operative management is even lower since the sensitivity of currently available diagnostic measures for predicting the pathological complete response hardly surpasses 50%-60%.The hereby proposed phase II trial CAO/ARO/AIO-16 aims at finding novel and innovative aspects of rectal cancer treatment. According to recently published data the radiochemotherapy regime in the present study with consolidating chemotherapy and delayed assessment of response has the potential to achieve pathological complete rates of approximately 40%. A standardized re-evaluation after consolidating chemotherapy will select patients who are candidates for organ-preservation. These patients will not undergo radical surgery and will instead be follow-up closely for tumor regrowth.

Patients will undergo different treatments based on response achieved after radiochemotherapy.

1. Clinical Complete Response: Omission of surgery and follow-up
2. Near clinical complete response: Reevaluation in three months
3. Poor / no response: Surgery

Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.

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

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

Possible scores range from 0 (perfect continence) to 24 (complete incontinence)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer	NCT02353858	Rectal Cancer Locally Advance... Hyperthermia Hyperthermic Ra... Hyperthermic Ch... Deep Regional H...	Deep regional h... Radiotherapy Chemotherapy (5...	18 Years - 80 Years	University Hospital Tuebingen
Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.	NCT03561142	Rectal Cancer Rectal Neoplasm... Rectal Cancer S... Rectal Cancer S...	Radiotherapy Chemotherapy Deep regional h...	18 Years -	University Hospital Tuebingen
Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.	NCT03561142	Rectal Cancer Rectal Neoplasm... Rectal Cancer S... Rectal Cancer S...	Radiotherapy Chemotherapy Deep regional h...	18 Years -	University Hospital Tuebingen
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer	NCT02353858	Rectal Cancer Locally Advance... Hyperthermia Hyperthermic Ra... Hyperthermic Ch... Deep Regional H...	Deep regional h... Radiotherapy Chemotherapy (5...	18 Years - 80 Years	University Hospital Tuebingen

Spots Global Cancer Trial Database for deep regional hyperthermia