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

Primary Purpose

Advanced Rectal Cancers

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Preoperative chemo-radiation with IG-IMRT dose escalation

About this trial

This is an interventional treatment trial for Advanced Rectal Cancers focused on measuring dose escalation, chemo-radiation, rectum cancer, phase 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy
Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy
Operable Patient
Age between 18 and 75
OMS performance status 0-2
No co-morbidity likely to prevent the delivery of treatment
Adequate contraception for men, and for non-menopausal women
Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL
Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS
Creatinine clearance> 50 mL / min
Patient must have been informed and must have signed the specific informed consent form.
Patient must be affiliated to a Social Health Insurance.

Exclusion Criteria:

Remote metastasis
Cancer not resectable
Contraindication to capecitabine and its excipients
Previous history of pelvic radiotherapy or previous chemotherapy
History of inflammatory bowel or rectum disease
History of angina pectoris monitored or myocardial infarction or heart failure
Active active infection or other serious underlying condition that may prevent the patient from receiving treatment
Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma
Patient already included in another therapeutic trial with an experimental molecule
Pregnant woman, likely to be pregnant or nursing
Persons deprived of their liberty or under guardianship
Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

Sites / Locations

CHRU de Besançon
Centre Gf Leclerc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

- 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)

Outcomes

Primary Outcome Measures

Complete histological response rate

Absence of residual cancer cells on the final analysis of the tumor and lymph node

Secondary Outcome Measures

Tolerance

Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0

Full Information

NCT ID

NCT03200249

First Posted

June 20, 2017

Last Updated

June 23, 2020

Sponsor

Centre Georges Francois Leclerc

1. Study Identification

Unique Protocol Identification Number

NCT03200249

Brief Title

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

Acronym

RADICAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

December 22, 2016 (Actual)

Primary Completion Date

December 22, 2016 (Actual)

Study Completion Date

January 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Rectal Cancers

Keywords

dose escalation, chemo-radiation, rectum cancer, phase 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Preoperative chemo-radiation with IG-IMRT dose escalation

Primary Outcome Measure Information:

Title

Complete histological response rate

Description

Absence of residual cancer cells on the final analysis of the tumor and lymph node

Time Frame

at 8 weeks after inclusion

Secondary Outcome Measure Information:

Title

Tolerance

Description

Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy Operable Patient Age between 18 and 75 OMS performance status 0-2 No co-morbidity likely to prevent the delivery of treatment Adequate contraception for men, and for non-menopausal women Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS Creatinine clearance> 50 mL / min Patient must have been informed and must have signed the specific informed consent form. Patient must be affiliated to a Social Health Insurance. Exclusion Criteria: Remote metastasis Cancer not resectable Contraindication to capecitabine and its excipients Previous history of pelvic radiotherapy or previous chemotherapy History of inflammatory bowel or rectum disease History of angina pectoris monitored or myocardial infarction or heart failure Active active infection or other serious underlying condition that may prevent the patient from receiving treatment Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma Patient already included in another therapeutic trial with an experimental molecule Pregnant woman, likely to be pregnant or nursing Persons deprived of their liberty or under guardianship Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

Facility Information:

Facility Name

CHRU de Besançon

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Name

Centre Gf Leclerc

City

Dijon

ZIP/Postal Code

21000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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

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