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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RtChx + Hyperthermia | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep regional hyperthermia | Other | Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | After surgical resection (4-6 weeks after last radiotherapy fraction) |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional progression free survival | 3 years | |
| Disease free survival | 3 years | |
| Distant metastases free survival |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tübingen, Department of Radiation Oncology | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33741467 | Derived | Gani C, Lamprecht U, Ziegler A, Moll M, Gellermann J, Heinrich V, Wenz S, Fend F, Konigsrainer A, Bitzer M, Zips D. Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial. Radiother Oncol. 2021 Jun;159:155-160. doi: 10.1016/j.radonc.2021.03.011. Epub 2021 Mar 17. |
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| Radiotherapy | Radiation | Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy. |
|
| Chemotherapy (5-Fluorouracil) | Drug | 5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day. |
|
| 3 years |
| Overall survival | 3 years |
| Number of hyperthermia treatments | At completion of hyperthermic radiochemotherapy |
| Acute and chronic treatment related toxicity, according to CTC criteria | 3 years |
| post operative morbidity | 3 years |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000084462 | Hyperthermia |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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