Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers

Advanced Rectal Cancers Clinical Trial

— RADICAL  

Official title:

Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200249
• Other study ID #: 2016-A01083-48
• Status: Completed
• Phase: N/A
• Start date: December 22, 2016
• Est. completion date: January 7, 2020

Study information

• Verified date: January 2020
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 7, 2020
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Rectal Cancers
• Rectal Neoplasms

Intervention

Radiation:
• Preoperative chemo-radiation with IG-IMRT dose escalation

Locations

Country	Name	City	State
France	CHRU de Besançon	Besançon
France	Centre Gf Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete histological response rate	Absence of residual cancer cells on the final analysis of the tumor and lymph node	at 8 weeks after inclusion
Secondary	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