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Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis
Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative chemo-radiation with IG-IMRT dose escalation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete histological response rate | Absence of residual cancer cells on the final analysis of the tumor and lymph node | at 8 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0 | at 1, 2, 3, 4, 5 and 13 weeks after inclusion and at 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Besançon | Besançon | 25030 | France | |||
| Centre Gf Leclerc |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Dijon |
| 21000 |
| France |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |