Clinical trial · Interventional
Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers
Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Rectal Cancers | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative chemo-radiation with IG-IMRT dose escalation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 1. \- Treatment : concomitant preoperative radio-chemotherapy (during 5 weeks) Chimiotherapy: Capecitabine 1600 mg/m2/j ; 5/7 days during the 5 weeks of radiotherapy Radiotherapy RT + SIB-IMRT (5 weeks ; 5 sessions/week ; 25 sessions): Pelvic prophylactic dose of 45 Gy (1,8 Gy/session); "boost" with a dose of 60 Gy on the tumor PTV (2,4 Gy/session) - Total dose: 60 Gy in 25 sessions during 5 weeks. 2. \- TME surgery (8 weeks after the end of treatment)
- interventionNames
- Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation
Primary outcomes (1)
- measure
- Complete histological response rate
- timeFrame
- at 8 weeks after inclusion
- description
- Absence of residual cancer cells on the final analysis of the tumor and lymph node
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available