Rectal CarcinomaPhase 3NACRENCT02551237
Neoadjuvant Treatment for Advanced Rectal Carcinoma
A Phase 3 study testing 50 Gy, Capecitabine and 25 Gy in people with Rectal Carcinoma, run by UNICANCER at 37 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- 50 Gy, Capecitabine and 25 Gy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 37 sitesFrance
- Study dates
- 7 Jan 2016to Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
France37 sites
Centre Hospitalier d'Abbeville
Abbeville
Clinique Claude Bernard
Albi
CHU Amiens Picardie
Amiens
Polyclinique Maymard
Bastia
Centre Hospitalier de Beauvais
Beauvais, 60021
CHU de Besançon
Besançon
Cebtre Hospitalier de Blois
Blois
Hôpital Avicenne
Bobigny
Institut Bergonié
Bordeaux
Centre François Baclesse
Caen
CHU Henri Mondor
Créteil
Centre Hospitalier de Dax
Dax
Centre Georges François Leclerc
Dijon
CHU DIJON (Hôpital du Bocage)
Dijon
CHIC des Alpes du Sud- site de Gap
Gap
CHU de Grenoble Hôpital A Michallon
Grenoble
Hôpital Privé Sainte Marguerite
Hyères
CHD de Vendée
La Roche-sur-Yon
Institut Hospitalier Franco-Britannique
Levallois-Perret
Centre Hospitalier Universitaire de Limoges
Limoges
Centre Léon Bérard
Lyon
Hôpital privé Jean Mermoz
Lyon
CHU Timone
Marseille
Institut Paoli Calmettes
Marseille
Centre azuréen de cancérologie
Mougins
Hôpital Américain de Paris
Neuilly-sur-Seine
Centre Antoine Lacassagne
Nice
Centre Médical Oncogard Institut de cancérologie du Gard
Nîmes
Chu Caremeau
Nîmes
Hôpital TENON
Paris
CHU de Bordeaux
Pessac
Centre Hospitalier Annecy Genevois
Pringy
Centre Henri Becquerel
Rouen
Hôpital d'instruction des Armées
Saint-Mandé
Clinique Pasteur
Toulouse
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Gustave Roussy Cancer Campus Grand Paris
Villejuif
About this study
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
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).
Read the detailed 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).
- Conditions
- Rectal Carcinoma
- Being tested
- 50 Gy, Capecitabine, 25 Gy
- Keywords
- Elderly patient, Radiotherapy, Radio chemotherapy, Neoadjuvant treatment
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 GyRadiation
radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks
CapecitabineDrug
Also called Xeloda
oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.
25 GyRadiation
radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: 25 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Compare the efficacy between the arm A and the arm B (with an objective of non-inferiority)
Measured: 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)
Measured: 1 year
Secondary outcomes (17)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.03
Description of the Adverse Events during the pre-operative period.
Measured: 3 months
Post-operative complications
according to Dindo-Clavien classification
Measured: 3 months
Death rate
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
Measured: at 6 and 12 months
Overall survival (OS)
The OS is defined as the interval between the date of randomization and the date of deaths from any cause
Measured: 10 years
Specific survival
The specific survival is defined as the interval between the date of randomization and the date of deaths due to cancer.
Measured: 10 years
Disease free survival
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.
Measured: 10 years
Loco-regional disease free survival
The disease free survival is defined as the interval between the date of randomization and the date of cancer relapse (local or regional).
Measured: 10 years
Rate of stoma
percentage of patients with definitive or transitional stoma after surgery.
Measured: at 6 and 12 months
Instrumental Activities of Daily Living (IADL)
Autonomy Assessment
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Activities of Daily Living (ADL)
Autonomy Assessment
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Questionnaire G8
Geriatric Screening
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Mini-Mental Score Examination (MMSE)
Cognitive functioning
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Walking gate
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Geriatric Depression Scale (GDS15)
Depression Assessment
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Charlson score
Comorbidities evaluation
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Mini Nutritional Assessment (MNA)
Nutritional Evaluation
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
EORTC QLQ-C30 + EDL14
Quality of Life (QLQ)
Measured: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start7 Jan 2016
- Primary completion29 Aug 2020
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Francois, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551237
- Sponsor's protocol ID
- PRODIGE 42 GERICO12/UCGI
- Other IDs
- 2015-A01365-44, UC-0103/1503
- Acronym
- NACRE
- Status last verified
- Oct 2023
- First submitted
- 31 Aug 2015
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36535196
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02551237
- Acronym / sponsor ID
- NACRE / PRODIGE 42 GERICO12/UCGI
- Conditions
- Rectal Carcinoma
- Keywords
- Elderly patient, Radiotherapy, Radio chemotherapy, Neoadjuvant treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiochemotherapy | Active comparator | Radiation: 50 Gy, Drug: CapecitabinePatients 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 |
| Radiotherapy | Experimental | Radiation: 25 GyPatients 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 Gyradiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks | Radiation | Radiochemotherapy |
| CapecitabineAlso: Xelodaoral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy. | Drug | Radiochemotherapy |
| 25 Gyradiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm) | Radiation | Radiotherapy |
Primary outcome
R0 resection rate
Time frame: 3 months
Compare the efficacy between the arm A and the arm B (with an objective of non-inferiority)
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)
17 secondary outcomes
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.03
Time frame: 3 months
Post-operative complications
Time frame: 3 months
Death rate
Time frame: at 6 and 12 months
Overall survival (OS)
Time frame: 10 years
Specific survival
Time frame: 10 years
Disease free survival
Time frame: 10 years
Loco-regional disease free survival
Time frame: 10 years
Rate of stoma
Time frame: at 6 and 12 months
Instrumental Activities of Daily Living (IADL)
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Activities of Daily Living (ADL)
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Questionnaire G8
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Mini-Mental Score Examination (MMSE)
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Walking gate
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Geriatric Depression Scale (GDS15)
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Charlson score
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Mini Nutritional Assessment (MNA)
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
EORTC QLQ-C30 + EDL14
Time frame: Baseline, within 2 weeks before surgery and 3, 6 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Derived from this study: PubMed 36535196Francois 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Francois principal investigator
Centre Antoine Lacassagne
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 50 Gy, Capecitabine and 25 Gy in people with Rectal Carcinoma, run by UNICANCER at 37 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.