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Trial record 1 of 2 for:    PRODIGE 42
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Neoadjuvant Treatment for Advanced Rectal Carcinoma (NACRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02551237
Recruitment Status : Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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).

Condition or disease Intervention/treatment Phase
Rectal Carcinoma Radiation: 50 Gy Drug: Capecitabine Radiation: 25 Gy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study Evaluating Two Neoadjuvant Treatments Radiochemotherapy (5 Weeks - 50Gy+Capecitabine) and Radiotherapy (1week - 25Gy) in Patient Over 75 With Locally Advanced Rectal Carcinoma
Actual Study Start Date : January 7, 2016
Actual Primary Completion Date : August 29, 2020
Estimated Study Completion Date : August 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Radiochemotherapy

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

Drug: Capecitabine
oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.
Other Name: Xeloda

Experimental: Radiotherapy

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




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 3 months ]
    Compare the efficacy between the arm A and the arm B (with an objective of non-inferiority)

  2. IADL (Instrumental Activities of Daily Living) Score [ Time Frame: 1 year ]
    Compare the maintenance of autonomy between the arm A and arm B (with an objective of superiority)


Secondary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.03 [ Time Frame: 3 months ]
    Description of the Adverse Events during the pre-operative period.

  2. Post-operative complications [ Time Frame: 3 months ]
    according to Dindo-Clavien classification

  3. Death rate [ Time Frame: at 6 and 12 months ]
    Death rate is defined as the percentage of patients who died since the date of randomisation at 6 and 12 months post-surgery (M6 and M12) from any cause

  4. Overall survival (OS) [ Time Frame: 10 years ]
    The OS is defined as the interval between the date of randomization and the date of deaths from any cause

  5. Specific survival [ Time Frame: 10 years ]
    The specific survival is defined as the interval between the date of randomization and the date of deaths due to cancer.

  6. Disease free survival [ Time Frame: 10 years ]
    The disease free survival is defined as the interval between the date of randomization and the date of cancer relapse (local regional or distant), second cancer or death from any cause.

  7. Loco-regional disease free survival [ Time Frame: 10 years ]
    The disease free survival is defined as the interval between the date of randomization and the date of cancer relapse (local or regional).

  8. Rate of stoma [ Time Frame: at 6 and 12 months ]
    percentage of patients with definitive or transitional stoma after surgery.

  9. Instrumental Activities of Daily Living (IADL) [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Autonomy Assessment

  10. Activities of Daily Living (ADL) [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Autonomy Assessment

  11. Questionnaire G8 [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Geriatric Screening

  12. Mini-Mental Score Examination (MMSE) [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Cognitive functioning

  13. Walking gate [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
  14. Geriatric Depression Scale (GDS15) [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Depression Assessment

  15. Charlson score [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Comorbidities evaluation

  16. Mini Nutritional Assessment (MNA) [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Nutritional Evaluation

  17. EORTC QLQ-C30 + EDL14 [ Time Frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery ]
    Quality of Life (QLQ)



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Public or private Health Insurance coverage
  • Patient has been informed and signed the informed consent document

Exclusion Criteria:

  • 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
  • Significant Cardiovascular diseases such as, but not limited to: cardiovascular or myocardial infarction ≤6 months before inclusion, congestive heart failure class II or higher (NYHA), unstable angina, arrhythmia requiring medication or uncontrolled hypertension;
  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551237


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Eric Francois Centre Antoine Lacassagne
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02551237    
Other Study ID Numbers: PRODIGE 42 GERICO12/UCGI
2015-A01365-44 ( Other Identifier: ID-RCB )
UC-0103/1503 ( Other Identifier: UNICANCER )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Keywords provided by UNICANCER:
Elderly patient
Radiotherapy
Radio chemotherapy
Neoadjuvant treatment
Additional relevant MeSH terms:
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Carcinoma
Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents