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A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Locally Advanced Malignant Neoplasm, Rectal Carcinoma

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Trial Information

A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma

Locally advanced rectal carcinoma raise the issue of both the oncological control, local and
general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients,
radiochemotherapy improves the local control but the metastatic risk remains about 30% with
enhanced postoperative morbidity and poor functional results. The tumor response to
preoperative treatment is the major prognostic factor which revealed the aggressiveness of
the tumor. To this day, there are no biologic predictive markers for tumor response.

The purpose of this trial is to tailor the management according to the early tumoral
response after short and intensive induction trichemotherapy. MRI volumetric tumor response
will be used to distinguish between good responders and bad responders.

"Very good" responders will be randomized to either immediate surgery or radiochemotherapy
followed by surgery (Standard arm: Cap 50). "Good or bad" responders will be randomized
between two arms: intensive radiochemotherapy (Cap 60) or the standard arm (Cap 50).

This tailored management should result in a better oncologic prognosis with a lower rate of
post therapeutic functional disorders.

Inclusion Criteria:

- Histologically confirmed rectal carcinoma

- Primary tumor evaluated by pelvic MR Imaging:

i) iT3 ≥c tumors, with MRI showing a predictive CRM ≤ 2 mm or a EMS (Extra Mural
Spread) ≥ 5 mm

ii) Resectable iT4 tumors (only randomized within the "poor responders" group)

iii) Any T tumors with MRI showing a predictive CRM ≤ 1 mm

- No detectable metastases: Thorax-abdomen-pelvic CT-scan

- Patient ≥ 18 years

- ECOG Performance Status 0-1-2

- Patient information and written informed consent form signed

- Patient who can receive radiotherapy and chemotherapy

- Negative pregnancy test in women of childbearing potential

- Patient covered by a Social Security system

- Hematology : Haemoglobin ≥ 9 g/dL, WBC ≥ 4000/mm3, neutrophils ≥ 1.5 x 109/L,
platelets ≥ 100 x 109/L

- Hepatic function : total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN, Alkaline
phosphatases ≤ 3 x ULN

- Renal function : creatinine ≤ 1.25 x ULN or creatinine clearance ≥ 60 ml/min

Exclusion Criteria:

- Indication for immediate surgery

- Primary tumor not measured at the MRI before inclusion

- Previous pelvic radiotherapy

- Contraindication to radiotherapy and/or chemotherapy

- Severe renal or liver impairment

- Cardiac and/or coronary disease which could contraindicate 5-Fu administration

- Active infectious disease

- Peripheral sensitive neuropathy

- History of prior cancer (except if it was cured more than 5 years ago, and if
complete remission)

- Patient (male or female) of reproductive potential not using an effective
contraceptive method during the whole treatment and up to 6 months after the
completion of treatment

- Concurrent participation in any other clinical trial likely to interfere with the
therapeutic schedule

- Fertile female patient not using adequate contraception, or breast-feeding woman

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ro resection rate

Outcome Description:

To confirm the feasibility of a tailored management with a 90% R0 resection rate achieved for all arms.

Outcome Time Frame:

Within 15 days after surgery

Safety Issue:


Principal Investigator

Philippe ROUANET, MD, Ph D

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle-Paul Lamarque


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

May 2011

Completion Date:

September 2019

Related Keywords:

  • Locally Advanced Malignant Neoplasm
  • Rectal Carcinoma
  • locally advanced rectal carcinoma
  • Tailored treatment strategy
  • MRI volumetry
  • Early tumor response
  • Neoplasms
  • Carcinoma
  • Rectal Neoplasms