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

• Sponsor: Centre Georges Francois Leclerc (Other)
• Overall Status: Completed
• CT.gov ID: NCT03200249
• Collaborator: (none)
• Enrollment: 15
• Locations: 2
• Arm: 1
• Actual Duration (Months): 36.5
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Rectal Cancers	Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)
• Actual Study Start Date: Dec 22, 2016
• Actual Primary Completion Date: Dec 22, 2016
• Actual Study Completion Date: Jan 7, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment - 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. - TME surgery (8 weeks after the end of treatment)

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Besançon	Besançon		France	25030
2	Centre Gf Leclerc	Dijon		France	21000

Sponsors and Collaborators

• Centre Georges Francois Leclerc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Georges Francois Leclerc
• ClinicalTrials.gov Identifier: NCT03200249
• Other Study ID Numbers: 2016-A01083-48
• First Posted: Jun 27, 2017
• Last Update Posted: Jun 24, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Centre Georges Francois Leclerc: dose escalation, chemo-radiation, rectum cancer, phase 2
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jun 24, 2020