Neoadjuvant Treatment for Advanced Rectal Carcinoma

NCT02551237 | Completed Phase 3 DMC

• 3 other identifiers: PRODIGE 42 GERICO12/UCGI2015-A01365-44UC-0103/1503
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 37

Brief Summary

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).

Conditions

Rectal Carcinoma

Keywords

Elderly patient; Radiotherapy; Radio chemotherapy; Neoadjuvant treatment

Outcome Measures

Primary Outcomes (2)

• R0 resection rate

  Compare the efficacy between the arm A and the arm B (with an objective of non-inferiority)

  3 months

• IADL (Instrumental Activities of Daily Living) Score

  Compare the maintenance of autonomy between the arm A and arm B (with an objective of superiority)

  1 year

Secondary Outcomes (17)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.03

  3 months

• Post-operative complications

  3 months

• Death rate

  at 6 and 12 months

• Overall survival (OS)

  10 years

• Specific survival

  10 years

Study Arms (2)

Radiochemotherapy

ACTIVE COMPARATOR

Patients who will be treated with * radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks associated with * oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy. The surgery will be planned 7 weeks (±1 week) after the end of preoperative treatment

Radiation: 50 Gy; Drug: Capecitabine

Radiotherapy

EXPERIMENTAL

Patients who will be treated with radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm) without chemotherapy. The surgery will be planned 7 weeks (±1 week) after the end of preoperative treatment

Radiation: 25 Gy

Interventions

50 Gy RADIATION

radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks

Radiochemotherapy

Capecitabine DRUG

oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.

Also known as: Xeloda

Radiochemotherapy

25 Gy RADIATION

radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm)

Radiotherapy

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient ≥75 years
• Eastern Cooperative Oncology Group (ECOG) ≤2
• Adenocarcinoma of the rectum histologically proven
• Tumor ≤12 cm from the anal margin, the measurement done by rigid rectoscopy or by sub peritoneal MRI
• Require a pre-operative treatment (tumor classified T3 or T4 resectable by MRI and tomodensitometry or T2 of the very low rectum)
• Patient operable
• No radiologically detectable metastases
• Absolute Neutrophile count (ANC) ≥1500/mm³; Platelets ≥100 000/mm³ and Hemoglobin ≥10 g/dL
• Bilirubin ≤1.5 x upper limit of normal (ULN), aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤1.5 x upper limit of normal (ULN), Alkaline Phosphatase ≤1.5 x upper limit of normal (ULN)
• Creatinine clearance ≥30 ml/min (Cockcroft and Gault)
• Uracilemia \< 16ng/mL
• Public or private Health Insurance coverage
• Patient has been informed and signed the informed consent document

You may not qualify if:

• Non-resectable tumor
• History of chronic diarrhea or an inflammatory disease of the colon or rectum, or intestinal obstruction or sub-obstruction
• History of pelvic radiotherapy
• Any active febrile infection or any other serious underlying pathology that may prevent the patient from receiving the treatment
• Significative cardiovascular conditions such as, but not limited to : Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery Symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA), clinically significant irregular heartbeat requiring medication
• Severe and unexpected reactions to fluoropyrimidine therapy
• Any contra-indication to capecitabine and its excipients; patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not included.
• Uracilemia ≥ 16ng/mL
• Any other concomitant cancer or history of cancer in the last 3 years, with the exception of the in situ cancer of the uterus, treated, or squamous-cell or basal-cell carcinoma.
• Patients already included in another therapeutic trail with an experimental molecule
• Person deprived of liberty
• Patient that for geographical, social and/or physical reasons will not be able to follow the procedure as required by the protocol

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (37)

Centre Hospitalier d'Abbeville

Abbeville, France

Location

Clinique Claude Bernard

Albi, France

Location

CHU Amiens Picardie

Amiens, France

Location

Polyclinique Maymard

Bastia, France

Location

Centre Hospitalier de Beauvais

Beauvais, 60021, France

Location

CHU de Besançon

Besançon, France

Location

Cebtre Hospitalier de Blois

Blois, France

Location

Hôpital Avicenne

Bobigny, France

Location

Institut Bergonié

Bordeaux, France

Location

Centre François Baclesse

Caen, France

Location

CHU Henri Mondor

Créteil, France

Location

Centre Hospitalier de Dax

Dax, France

Location

Centre Georges François Leclerc

Dijon, France

Location

CHU DIJON (Hôpital du Bocage)

Dijon, France

Location

CHIC des Alpes du Sud- site de Gap

Gap, France

Location

CHU de Grenoble Hôpital A Michallon

Grenoble, France

Location

Hôpital Privé Sainte Marguerite

Hyères, France

Location

CHD de Vendée

La Roche-sur-Yon, France

Location

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Location

Centre Hospitalier Universitaire de Limoges

Limoges, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital privé Jean Mermoz

Lyon, France

Location

CHU Timone

Marseille, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Centre azuréen de cancérologie

Mougins, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Centre Médical Oncogard Institut de cancérologie du Gard

Nîmes, France

Location

Chu Caremeau

Nîmes, France

Location

Hôpital TENON

Paris, France

Location

CHU de Bordeaux

Pessac, France

Location

Centre Hospitalier Annecy Genevois

Pringy, France

Location

Centre Henri Becquerel

Rouen, France

Location

Hôpital d'instruction des Armées

Saint-Mandé, France

Location

Clinique Pasteur

Toulouse, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, France

Location

Related Publications (1)

• Francois E, De Bari B, Ronchin P, Nouhaud E, Martel-Lafay I, Artru P, Clavere P, Vendrely V, Boige V, Gargot D, Lemanski C, De Sousa Carvalho N, Gal J, Pernot M, Magne N. Comparison of short course radiotherapy with chemoradiotherapy for locally advanced rectal cancers in the elderly: A multicentre, randomised, non-blinded, phase 3 trial. Eur J Cancer. 2023 Feb;180:62-70. doi: 10.1016/j.ejca.2022.11.020. Epub 2022 Nov 28.

  PMID: 36535196 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Eric Francois

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 16, 2015
• Study Start: January 7, 2016
• Primary Completion: August 29, 2020
• Study Completion: June 1, 2022
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

FR (37)