Rectal CancerQRAAPNCT07764120
Quality of Life of Patients After Rectal Cancer Resection .
An observational study of Rectal Cancer, run by University Hospital, Grenoble.
Trial summary
Surgical treatment of cancer of the lower rectum by resection and coloanal anastomosis or abdominoperineal resection in both cases exposes the patient to significant functional digestive sequelae (anal incontinence or permanent stoma), and also to urinary and sexual consequences, which have a major impact on quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over the age of 18 and presenting a locally advanced non-metastatic cancer of the lower rectum (stage II or stage III), requiring, after neoadjuvant chemoradiotherapy (whatever type), a total excision of the mesorectum followed either by abdominoperineal resection or manual coloanal anastomosis, may be included in the study, after signing the written consent form.
Who may be able to join
- Patients over 18 years
- Patient operated on for adenocarcinoma of the lower rectum without metastasis
- Total mesorectal excision (TME) surgery for cancer
- Patients who underwent coloanal anastomosis or abdominoperineal amputation, regardless of the method and approach, between January 2005 and December 2021
- Patients' information and non-opposition
Who cannot join
- Double localisation of colorectal cancer during surgery
- Resection of another organ due to invasion (T4 tumours)
- Chemotherapy for recurrence or metastasis during follow-up
- Surgical complication of coloanal anastomosis requiring permanent stoma
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quality of Life at 3 Years of Patients Treated by Abdominoperineal Resection or Rectal Resection and Coloanal Anastomosis for Cancer of the Lower Rectum.
Surgical treatment of cancer of the lower rectum by resection and coloanal anastomosis or abdominoperineal resection in both cases exposes the patient to significant functional digestive sequelae (anal incontinence or permanent stoma), and also to urinary and sexual consequences, which have a major impact on quality of life.
Locally advanced rectal cancers leading to one or the other of these two procedures have practically the same characteristics: always fairly large cancers, located in the distal third of the rectum, in most cases requiring neoadjuvant chemoradiotherapy and a temporary or permanent stoma.
Read more
Recent surgical advances and improved adjuvant therapy are increasingly steering patients toward "at all costs" sphincter preservation, sometimes at the expense of quality of life.
Abdominoperineal resection with permanent ostomy is classically believed to have a detrimental effect on quality of life compared with resection and low anastomosis. Very few studies have compared these two procedures in terms of long-term functional results and quality of life. Most of them are small and/or retrospective case series, involve heterogeneous populations, or use questionable methodology.
As randomized patients between sacrifice or preservation of the anus, seem not ethical, the study propose to compare in a prospective single-center study two very close populations of patients presenting advanced cancer of the lower rectum after chemoradiotherapy, treated by abdominoperineal resection or resection and coloanal anastomosis, with the objective to determine long-term quality of life.
Most studies, including the recent prospective one, showed no substantial difference between the two procedures in terms of quality of life or functional difficulties. With the caveat of the biases, sphincter conservation would nevertheless seem that is associated with a better quality of life.The aim of this single-centre retrospective study is to compare the quality of life over more than three years in a population of patients with locally advanced lower rectal cancer who underwent surgery after chemoradiotherapy, either rectal resection and coloanal anastomosis or abdominoperineal amputation.
This study might conclude that one procedure is superior to the other in terms of quality of life and help to choose the best technique, which could lead to substantial changes in the management of advanced cancers of the lower rectum.
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, abdominoperineal resection, rectal resection, coloanal anastomosis, quality of life, genitourinary disorders
- Medical subject headings
- Rectal Neoplasms, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated by rectal resection and coloanal anastomosis. | Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after radiochemotherapy by rectal resection and coloanal anastomosis. | |
| Patients operated by abdominoperineal amputation. | Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after chemoradiotherapy by rectal resection and abdominoperineal amputation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal.
Quality of life questionnaire:
- EORTC-QLQ C30 (European organization for Research and Treatment of Cancer, colorectal cancer-specific quality of life questionnaire module. 30 items. min score = 30, max = 126)
Measured: Baseline
Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal.
Quality of life questionnaire:
- EORTC-QR29 (European organization for Research and Treatment of Cancer, colorectal cancer module, 29 items. min score = 29, max = 116)
Measured: Baseline
Secondary outcomes (10)
Study of specific quality of life
Quality of life questionnaires:
- EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels, minimum score = 0, maximum = 25)
Measured: Baseline
Study of specific quality of life
Quality of life questionnaires:
- FACT-C (Functional Assessment of Cancer Therapy - Colorectal, minimum = 0, maximum = 136
Measured: Baseline
Study of specific quality of life
Quality of life questionnaires:
- HAD (Hospital Anxiety and Depression Scale, min = 0, maximum = 42)
Measured: Baseline
Study of specific quality of life
Quality of life questionnaires:
- SF 36 (Short Form-36 Health Survey, min = 0, maximum = 100)
Measured: Baseline
Study of specific quality of life
Quality of life questionnaires:
- Stoma-QOL (Stoma Quality of Life Questionnaire, min = 0, maximum = 100)
Measured: Baseline
Study of specific quality of life
Quality of life questionnaires:
- LARS (Low Anterior Resection Syndrome, min = 0, max = 42)
Measured: Baseline
Study of specific quality of life
Quality of life questionnaires:
- EORTC QLQ-ELD14 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Elderly Cancer Patients Module, min = 0, max = 100)
Measured: Baseline
Morbidity rate on D90 according to Dindo Clavien - nature of the complications
Severe complication rate (Dindo Clavien ≥ 3)
Measured: 90 days
Length of a hospital stay
Number of days of hospitalization and hospital stays
Measured: 30 days
overall survival
Kaplan-Meier curves
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startAug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764120
- Sponsor's protocol ID
- 38RC25.0226
- Acronym
- QRAAP
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grumann MM, Noack EM, Hoffmann IA, Schlag PM. Comparison of quality of life in patients undergoing abdominoperineal extirpation or anterior resection for rectal cancer. Ann Surg. 2001 Feb;233(2):149-56. doi: 10.1097/00000658-200102000-00001.
PubMed 11176118Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Gujral S, Conroy T, Fleissner C, Sezer O, King PM, Avery KN, Sylvester P, Koller M, Sprangers MA, Blazeby JM; European Organisation for Research and Treatment of Cancer Quality of Life Group. Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer. 2007 Jul;43(10):1564-73. doi: 10.1016/j.ejca.2007.04.005. Epub 2007 May 22.
PubMed 17521904Pachler J, Wille-Jorgensen P. Quality of life after rectal resection for cancer, with or without permanent colostomy. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004323. doi: 10.1002/14651858.CD004323.pub4.
PubMed 23235607Sprangers MA, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999 Feb;35(2):238-47. doi: 10.1016/s0959-8049(98)00357-8.
PubMed 10448266Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Kang SB, Cho JR, Jeong SY, Oh JH, Ahn S, Choi S, Kim DW, Lee BH, Youk EG, Park SC, Heo SC, Lee DS, Ryoo SB, Park JW, Park HC, Lee SM, Kang SI, Kim MH, Oh HK, Shin R, Kim MJ, Lee KH, Kim YH, Kim JS, Lee KW, Lee HS, Kim HJ, Park YS, Sohn DK, Park KJ; Seoul Colorectal Research Group (SECOG). Quality of life after sphincter preservation surgery or abdominoperineal resection for low rectal cancer (ASPIRE): A long-term prospective, multicentre, cohort study. Lancet Reg Health West Pac. 2020 Dec 28;6:100087. doi: 10.1016/j.lanwpc.2020.100087. eCollection 2021 Jan.
PubMed 34327411Russell MM, Ganz PA, Lopa S, Yothers G, Ko CY, Arora A, Atkins JN, Bahary N, Soori GS, Robertson JM, Eakle J, Marchello BT, Wozniak TF, Beart RW Jr, Wolmark N. Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04. Ann Surg. 2015 Jan;261(1):144-8. doi: 10.1097/SLA.0000000000000594.
PubMed 24670844How P, Stelzner S, Branagan G, Bundy K, Chandrakumaran K, Heald RJ, Moran B. Comparative quality of life in patients following abdominoperineal excision and low anterior resection for low rectal cancer. Dis Colon Rectum. 2012 Apr;55(4):400-6. doi: 10.1097/DCR.0b013e3182444fd1.
PubMed 22426263Cornish JA, Tilney HS, Heriot AG, Lavery IC, Fazio VW, Tekkis PP. A meta-analysis of quality of life for abdominoperineal excision of rectum versus anterior resection for rectal cancer. Ann Surg Oncol. 2007 Jul;14(7):2056-68. doi: 10.1245/s10434-007-9402-z. Epub 2007 Apr 13.
PubMed 17431723Camilleri-Brennan J, Steele RJ. Quality of life after treatment for rectal cancer. Br J Surg. 1998 Aug;85(8):1036-43. doi: 10.1046/j.1365-2168.1998.00808.x.
PubMed 9717993Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X.
PubMed 22935240
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life at 3 Years of Patients Treated by Abdominoperineal Resection or Rectal Resection and Coloanal Anastomosis for Cancer of the Lower Rectum.
- ClinicalTrials.gov ID
- NCT07764120
- Acronym / sponsor ID
- QRAAP / 38RC25.0226
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, abdominoperineal resection, rectal resection, coloanal anastomosis, quality of life, genitourinary disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Aug 2026 (actual)
- 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.
Surgical treatment of cancer of the lower rectum by resection and coloanal anastomosis or abdominoperineal resection in both cases exposes the patient to significant functional digestive sequelae (anal incontinence or permanent stoma), and also to urinary and sexual consequences, which have a major impact on quality of life.
Locally advanced rectal cancers leading to one or the other of these two procedures have practically the same characteristics: always fairly large cancers, located in the distal third of the rectum, in most cases requiring neoadjuvant chemoradiotherapy and a temporary or permanent stoma.
Recent surgical advances and improved adjuvant therapy are increasingly steering patients toward "at all costs" sphincter preservation, sometimes at the expense of quality of life.
Abdominoperineal resection with permanent ostomy is classically believed to have a detrimental effect on quality of life compared with resection and low anastomosis. Very few studies have compared these two procedures in terms of long-term functional results and quality of life. Most of them are small and/or retrospective case series, involve heterogeneous populations, or use questionable methodology.
As randomized patients between sacrifice or preservation of the anus, seem not ethical, the study propose to compare in a prospective single-center study two very close populations of patients presenting advanced cancer of the lower rectum after chemoradiotherapy, treated by abdominoperineal resection or resection and coloanal anastomosis, with the objective to determine long-term quality of life.
Most studies, including the recent prospective one, showed no substantial difference between the two procedures in terms of quality of life or functional difficulties. With the caveat of the biases, sphincter conservation would nevertheless seem that is associated with a better quality of life.The aim of this single-centre retrospective study is to compare the quality of life over more than three years in a population of patients with locally advanced lower rectal cancer who underwent surgery after chemoradiotherapy, either rectal resection and coloanal anastomosis or abdominoperineal amputation.
This study might conclude that one procedure is superior to the other in terms of quality of life and help to choose the best technique, which could lead to substantial changes in the management of advanced cancers of the lower rectum.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients operated by rectal resection and coloanal anastomosis. | – | –Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after radiochemotherapy by rectal resection and coloanal anastomosis. |
| Patients operated by abdominoperineal amputation. | – | –Patients with locally advanced, non-metastatic cancer of the lower rectum, operated after chemoradiotherapy by rectal resection and abdominoperineal amputation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over the age of 18 and presenting a locally advanced non-metastatic cancer of the lower rectum (stage II or stage III), requiring, after neoadjuvant chemoradiotherapy (whatever type), a total excision of the mesorectum followed either by abdominoperineal resection or manual coloanal anastomosis, may be included in the study, after signing the written consent form.
Key inclusion criteria (5 listed)
- Patients over 18 years
- Patient operated on for adenocarcinoma of the lower rectum without metastasis
- Total mesorectal excision (TME) surgery for cancer
- Patients who underwent coloanal anastomosis or abdominoperineal amputation, regardless of the method and approach, between January 2005 and December 2021
- Patients' information and non-opposition
Key exclusion criteria (4 listed)
- Double localisation of colorectal cancer during surgery
- Resection of another organ due to invasion (T4 tumours)
- Chemotherapy for recurrence or metastasis during follow-up
- Surgical complication of coloanal anastomosis requiring permanent stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal.
Time frame: Baseline
Quality of life questionnaire: * EORTC-QLQ C30 (European organization for Research and Treatment of Cancer, colorectal cancer-specific quality of life questionnaire module. 30 items. min score = 30, max = 126)
Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal.
Time frame: Baseline
Quality of life questionnaire: * EORTC-QR29 (European organization for Research and Treatment of Cancer, colorectal cancer module, 29 items. min score = 29, max = 116)
10 secondary outcomes
Study of specific quality of life
Time frame: Baseline
Study of specific quality of life
Time frame: Baseline
Study of specific quality of life
Time frame: Baseline
Study of specific quality of life
Time frame: Baseline
Study of specific quality of life
Time frame: Baseline
Study of specific quality of life
Time frame: Baseline
Study of specific quality of life
Time frame: Baseline
Morbidity rate on D90 according to Dindo Clavien - nature of the complications
Time frame: 90 days
Length of a hospital stay
Time frame: 30 days
overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 11176118Grumann MM, Noack EM, Hoffmann IA, Schlag PM. Comparison of quality of life in patients undergoing abdominoperineal extirpation or anterior resection for rectal cancer. Ann Surg. 2001 Feb;233(2):149-56. doi: 10.1097/00000658-200102000-00001.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 17521904Gujral S, Conroy T, Fleissner C, Sezer O, King PM, Avery KN, Sylvester P, Koller M, Sprangers MA, Blazeby JM; European Organisation for Research and Treatment of Cancer Quality of Life Group. Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer. 2007 Jul;43(10):1564-73. doi: 10.1016/j.ejca.2007.04.005. Epub 2007 May 22.
- Background: PubMed 23235607Pachler J, Wille-Jorgensen P. Quality of life after rectal resection for cancer, with or without permanent colostomy. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004323. doi: 10.1002/14651858.CD004323.pub4.
- Background: PubMed 10448266Sprangers MA, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999 Feb;35(2):238-47. doi: 10.1016/s0959-8049(98)00357-8.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 34327411Kang SB, Cho JR, Jeong SY, Oh JH, Ahn S, Choi S, Kim DW, Lee BH, Youk EG, Park SC, Heo SC, Lee DS, Ryoo SB, Park JW, Park HC, Lee SM, Kang SI, Kim MH, Oh HK, Shin R, Kim MJ, Lee KH, Kim YH, Kim JS, Lee KW, Lee HS, Kim HJ, Park YS, Sohn DK, Park KJ; Seoul Colorectal Research Group (SECOG). Quality of life after sphincter preservation surgery or abdominoperineal resection for low rectal cancer (ASPIRE): A long-term prospective, multicentre, cohort study. Lancet Reg Health West Pac. 2020 Dec 28;6:100087. doi: 10.1016/j.lanwpc.2020.100087. eCollection 2021 Jan.
- Background: PubMed 24670844Russell MM, Ganz PA, Lopa S, Yothers G, Ko CY, Arora A, Atkins JN, Bahary N, Soori GS, Robertson JM, Eakle J, Marchello BT, Wozniak TF, Beart RW Jr, Wolmark N. Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04. Ann Surg. 2015 Jan;261(1):144-8. doi: 10.1097/SLA.0000000000000594.
- Background: PubMed 22426263How P, Stelzner S, Branagan G, Bundy K, Chandrakumaran K, Heald RJ, Moran B. Comparative quality of life in patients following abdominoperineal excision and low anterior resection for low rectal cancer. Dis Colon Rectum. 2012 Apr;55(4):400-6. doi: 10.1097/DCR.0b013e3182444fd1.
- Background: PubMed 17431723Cornish JA, Tilney HS, Heriot AG, Lavery IC, Fazio VW, Tekkis PP. A meta-analysis of quality of life for abdominoperineal excision of rectum versus anterior resection for rectal cancer. Ann Surg Oncol. 2007 Jul;14(7):2056-68. doi: 10.1245/s10434-007-9402-z. Epub 2007 Apr 13.
- Background: PubMed 9717993Camilleri-Brennan J, Steele RJ. Quality of life after treatment for rectal cancer. Br J Surg. 1998 Aug;85(8):1036-43. doi: 10.1046/j.1365-2168.1998.00808.x.
- Background: PubMed 22935240Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University Hospital, Grenoble.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astrid LAURENT (+33 (0)4 76 76 70 79, ALaurent7@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of overall quality of life over more than 3 years in a population of patients with locally advanced, non-metastatic cancer of the lower rectum, operated on after chemoradiotherapy by rectal resection and coloanal anastomosis, or abdominoperineal. (time frame: Baseline). 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 NCT07764120, which also lists 12 linked publications.
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 Aug 2026.