Last updated on February 2018

Neoadjuvant Treatment for Advanced Rectal Carcinoma

Brief description of study

The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

Detailed Study Description

Colorectal cancer is one of the most frequent cancers diagnosed in France. The average age of diagnosis in 2012 was 70 years old for men and 73 years for women, confirming that colorectal cancer is a disease of the elderly population.

The literature concerning combined treatments of colorectal cancer in the elderly is extremely limited. The application of combined treatments in the geriatric population is associated with an increase in the therapeutic complications. These post-operative complications together with the comorbidities and age are unfavorable prognostic factors for survival in patients with cancer of the rectum; this explains why the improved results obtained during the last decades are perceptible in younger patients and not in the elderly.

In the general population, pre-operative radio-chemotherapy has imposed itself as a standard treatment for the cancer of the rectum locally advanced. The utilization of fluoropyrimidines associated with radiotherapy (RT) delivered in fractions [long course RT (50 Gy in 5 weeks), surgery planned 6 to 8 weeks later] increases the complete histological response rate and decreases significantly the rate of local relapse.

The short-course RT [short course RT using the Swedish model (5x5 Gy in 5 days), with the surgery programmed the following week] is the standard neoadjuvant protocol in an important number of countries and/or academic groups. The studies that have compared the fractioned RT scheme to the short-course RT protocols have not shown any evidence of a change in efficacy of the short course RT concerning the following criteria: rate of R0 resection, rate of sphincter conservation, rate of relapse at 3 years, the disease free survival or the overall survival. Similarly, there appears to be no difference in severe toxicities in the long term. It should however be noted that short-course RT followed by immediate surgery may be less efficient than combined treatment in patients with a distal T3 cancer, even though these conclusions published by Ngan have been criticized by certain. On the other hand, the fractioned combined treatments results in more tumor and stage reduction and thus more sterilization.

Nevertheless a retrospective analysis, performed in the Stockholm region, in patients irradiated with short-course protocol but operated with a delay of at least 4 weeks resulted in a sterilization rate of 8%. This result is even more interesting since in this cohort, 46% of the patients had a tumor classified T4 and that 38% of the patients had a primitive tumor considered inoperable.

In the elderly population, the neoadjuvant treatment has rarely been studied. An exploratory analysis of the PRODIGE 2 study, based on age as the criteria, has shown that pre-operative radio-chemotherapy is significantly more toxic in the elderly population, from 70 years of age. Globally the lower tolerance for the pre-operative radio-chemotherapy results in more frequent early termination of RT and a statistically significant decrease in the number of patients operated. Furthermore, if the type of surgery was not significantly different between patients <70 years and those 70 years, we observe a non-significant increase in the rate of prolonged stoma (patients amputated without closure of the stoma). These differences in the surgical procedures is also observed in other publications, placing the emphasis on the fact that in the absence of any difference in the clinical presentation or the characteristic of the tumor, the risk of real or supposed decompensation modifies the surgical care. These data, as well as those in the literature, provides evidence that the pre-operative radio-chemotherapy strategy followed by surgery, the standard strategy in younger patients, is associated with more side effects in the elderly, resulting in the benefit-risk balance, in this population, to be more questionable.

It is therefore necessary to conduct a specific studies in the elderly population, with cancer of the rectum with the objective to maintain the carcinological results obtained with classical radio-chemotherapy with at the same time better controlling the secondary effects of the treatment and the risk of decompensation of the patients: the short course radiotherapy associated with a delayed surgery may be a therapeutic scheme well adapted to this population.

The investigators therefore propose a study comparing pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

Clinical Study Identifier: NCT02551237

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Clinique Claude Bernard
Albi, France
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Alexandre COUTTE

CHU Amiens Picardie
Amiens, France
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Polyclinique Maymard
Bastia, France
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Centre Hospitalier de Beauvais
Beauvais, France
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CHU de Besan on
Besancon, France
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Institut Bergoni
Bordeaux, France
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Centre Georges Fran ois Leclerc
Dijon, France
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CHIC des Alpes du Sud- site de Gap
GAP, France
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Jean-François BERDAH

H pital Priv Sainte Marguerite
Hyeres, France
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Véronique GIRRE

CHD de Vend e
La Roche-sur-yon, France
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Institut Hospitalier Franco-Britannique
Levallois-perret, France
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Centre L on B rard
Lyon, France
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Pascal Artru

H pital priv Jean Mermoz
Lyon, France
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Institut Paoli Calmettes
Marseille, France
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Philippe RONCHIN

Centre azur en de canc rologie
Mougins, France
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Eric Francois

Centre Antoine Lacassagne
Nice, France
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Chu Caremeau
Nimes, France
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Véronique VENDRELY

CHU de Bordeaux
Pessac, France
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Emmanuel Maillard

Centre Hospitalier Annecy Genevois
Pringy, France
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Centre Henri Becquerel
Rouen, France
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H pital d'instruction des Arm es
Saint Mande, France
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Clinique Pasteur
Toulouse, France
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Valérie Boige

Gustave Roussy Cancer Campus Grand Paris
Villejuif, France
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Centre Hospitalier d'Abbeville
Abbeville, France
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Cebtre Hospitalier de Blois
Blois, France
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H pital Avicenne
Bobigny, France
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Che Mabubu,Claude M'VONDO

Centre Fran ois Baclesse
Caen, France
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CHU Henri Mondor
Créteil, France
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Centre Hospitalier de Dax
Dax, France
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Jean Louis JOUVE

CHU DIJON (H pital du Bocage)
Dijon, France
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CHU de Grenoble H pital A Michallon
Grenoble, France
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Centre Hospitalier Universitaire de Limoges
Limoges, France
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Jean-François SEITZ

CHU Timone
Marseille, France
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H pital Am ricain de Paris
Neuilly-sur-seine, France
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Jacques CRETIN

Centre M dical Oncogard Institut de canc rologie du Gard
Nîmes, France
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Florence HUGUET

H pital TENON
Paris, France
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Institut de Canc rologie de Lorraine
Vandoeuvre Les Nancy, France
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