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This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose Radiotherapy | Active Comparator |
| |
| Chemo-radiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose radiotherapy | Radiation | Preoperative radiotherapy of 45 Gy/25 fractions of 1.8 Gy through three fields was delivered to the pelvis over 5 weeks, followed by a 18 Gy/10 fraction boost to the primary tumor over 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Sphincter preservation rate | surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response according to rectal endo-echography | prior to surgery | |
| operative mortality and morbidity | after surgery | |
| anatomopathology margins (lateral and inferior) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Rouanet, Pr | CRLC Val d'Aurelle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte catherine | Avignon | France | ||||
| Hopital Saint Andre |
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|
| Chemo-radiotherapy | Radiation | Chemotherapy (5-fluorouracil, 200 mg per square meter of body-surface area per day) was delivered over 5 weeks concurrently with the pelvic radiotherapy. |
|
|
| after surgery |
| Functional results (stoma closure, continence, manometry) | 2 years |
| Local recurrence | 3 years |
| Disease-free survival | 3 years |
| Overall Survival | 4 years |
| Bordeaux |
| France |
| Hotel Dieu | Clermont-Ferrand | France |
| Hopital Michallon | Grenoble | France |
| Centre Oscar Lambret | Lille | France |
| CAC Léon Bérard | Lyon | France |
| Institut Paoli Calmettes | Marseille | France |
| CRLC Val d'Aurelle | Montpellier | France |
| Hopital Saint Eloi | Montpellier | France |
| Centre Rene Gauducheau | Nantes | France |
| Centre Paul Strauss | Strasbourg | France |
| Institut Gustave Roussy | Villejuif | France |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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