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Terminated after interim analysis
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.
Adenocarcinoma of the rectum
Stage II/stage III rectal cancer (if T4 only anal extension eligible)
Drug: UFT
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Procedure: radiosensitization
Procedure: surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegafur uracile + radiotherapy | Experimental |
| |
| radiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegafur and Uracil | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone |
| Measure | Description | Time Frame |
|---|---|---|
| Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone. | ||
| Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30]) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Other
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Cellier, MD | Institut Cancerologie de l'Ouest | Study Chair |
| Rémy Barraya, MD | Institut Cancerologie de l'Ouest | Study Chair |
| Christian Chevelle, MD | Centre des Hautes Energie, Toulouse | Study Chair |
| Gérard Lorimier, MD | Institut Cancerologie de l'Ouest | Study Chair |
| Véronique Verrièle, MD | Institut Cancerologie de l'Ouest | Study Chair |
| Michèle Boisdron, Pct, PhD | Institut Cancerologie de l'Ouest | Study Chair |
| Loïc Campion, MD | Centre René Gauducheau, Nantes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Sainte Catherine | Avignon | 84000 | France | |||
| Hopital Avicenne |
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| Compare the rate of sphincter conservation alone. |
| Compare the safety of the chemoradiotherapy regimen to radiotherapy alone |
| Compare the rate of resectability with negative resection margins in patients treated with this two regimen. |
| Compare recurrence free survival and disease free survival |
| Compare overall survival |
| Bobigny |
| 93 |
| France |
| Institut de Cancérologie et d'Hématologie | Brest | 29609 | France |
| Centre Hospitalier | Brive-la-Gaillarde | 19312 | France |
| Centre d'Oncologie-radiothérapie d'Eure et Loir | Chartres | 28006 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Médical République | Clermont-Ferrand | 63023 | France |
| Clinique du Mail | Grenoble | 38100 | France |
| Centre Hospitalier Départemental | La Roche-sur-Yon | 85025 | France |
| Centre Guillaume le Conquérant | Le Havre | 76600 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Hospitalier | Lorient | 56322 | France |
| Centre léon Bérard | Lyon | 69373 | France |
| Centre Gray | Maubeuge | 59600 | France |
| Clinique du Pont de Chaume | Montauban | 82017 | France |
| Polyclinique St Roch | Montpellier | 34967 | France |
| Centre Hospitalier | Niort | 79021 | France |
| Clinique Valdegour | Nîmes | 30900 | France |
| Centre Hospitalier Universitaire | Poitiers | 86021 | France |
| Centre Hospitalier de Cornouaille | Quimper | 29000 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Centre Hospitalier | Rodez | 12027 | France |
| Centre Frédéric Joliot | Rouen | 76000 | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | 22015 | France |
| Centre de Radiothérapie | Strasbourg | 67000 | France |
| Centre des Hautes Energies | Toulouse | 31400 | France |
| Clinique Fleming | Tours | 37000 | 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 |
|---|---|
| D005641 | Tegafur |
| D014498 | Uracil |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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