Advanced Rectal Cancers
Conditions
Keywords
dose escalation, chemo-radiation, rectum cancer, phase 2
Brief summary
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.
Interventions
RADIATIONPreoperative chemo-radiation with IG-IMRT dose escalation
Sponsors
Centre Georges Francois Leclerc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy 2. Tumor \<15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI 3. Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy 4. Operable Patient 5. Age between 18 and 75 6. OMS performance status 0-2 7. No co-morbidity likely to prevent the delivery of treatment 8. Adequate contraception for men, and for non-menopausal women 9. Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL 10. Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS 11. Creatinine clearance\> 50 mL / min 12. Patient must have been informed and must have signed the specific informed consent form. 13. Patient must be affiliated to a Social Health Insurance.
Exclusion criteria
1. Remote metastasis 2. Cancer not resectable 3. Contraindication to capecitabine and its excipients 4. Previous history of pelvic radiotherapy or previous chemotherapy 5. History of inflammatory bowel or rectum disease 6. History of angina pectoris monitored or myocardial infarction or heart failure 7. Active active infection or other serious underlying condition that may prevent the patient from receiving treatment 8. Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma 9. Patient already included in another therapeutic trial with an experimental molecule 10. Pregnant woman, likely to be pregnant or nursing 11. Persons deprived of their liberty or under guardianship 12. Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete histological response rate | at 8 weeks after inclusion | Absence of residual cancer cells on the final analysis of the tumor and lymph node |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 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 | Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0 |
Countries
France
Outcome results
None listed