Medium and Lower Rectal CancerPhase 2CASCADORNCT01876901

Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)

A Phase 2 study testing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) and Colo-anal anastomosis (CAA) in people with Medium and Lower Rectal Cancer, run by Institut Bergonié at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Hypothesis: In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon cancer, technical management remains challenging with unresolved operating difficulties. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Medium and Lower Rectal Cancer
What is being tested?: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) and Colo-anal anastomosis (CAA)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 9 sitesFrance
Study dates: 11 Aug 2010to 14 Feb 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically proven rectal adenocarcinoma.
Medium or lower rectum tumour requiring removal of the entire rectum and its mesorectum.
T1 N+ or T2 N+ or T3 N+ or T3 N0 and M0 tumour.
Age between 18 and 75 years .
ASA ≤ 2.
Sphincter continence compatible with coloanal anastomosis.

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Patients who received preoperative radiotherapy alone or chemotherapy and radiotherapy.
Patient affiliated to social security.
For patients of childbearing age, use of contraception.
Patient information and consent for study participation

Who cannot join

Other histology of rectal cancer.
T1 N0 or T2 N0 or T4 tumour.
Metastatic disease M1.
History of cancer except cervix in situ carcinoma or skin basal cell carcinoma.
Patient with psychological, social, family or geographical reasons who couldn't be treated or monitored regularly by the criteria of the study
Patients deprived of liberty or under guardianship.
Pregnant or nursing women.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

France9 sites

CHU DE BORDEAUX - Hôpital Saint André
Bordeaux, Aquitaine, 33000
Institut Bergonié
Bordeaux, Aquitaine, 33000
CHU de GRENOBLE
Grenoble, Auvergne-Rhône-Alpes, 38000
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69000
HOSPICES CIVILS DE LYON - Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, 69000
Institut Paoli Calmettes
Marseille, Bouche Du Rhône, 13000
Chu de Nancy
Nancy, Lorraine, 54000
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, Lorraine, 54000
Clinique Du Tonkin
Villeurbanne, Auvergne-Rhône-Alpes, 69000

Other trials in France

About this study

Official title: Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.

Hypothesis:

In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon cancer, technical management remains challenging with unresolved operating difficulties. Morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations.

Reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate of fistula that results is reported in the literature between 15 and 25%.

An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and mortality are reduced, and patient's quality of life greatly improved. Direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced.

This study is a multicentre, two arms, phase 2 clinical trial.

Conditions: Medium and Lower Rectal Cancer
Being tested: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA), Colo-anal anastomosis (CAA)
Keywords: Rectal cancer, Coloanal anastomosis, Phase 2 clinical trial
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)Procedure or surgery
2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.
After surgical resection, the colon is exteriorized through the anus and attached to the buttock.
By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation
Colo-anal anastomosis (CAA)Procedure or surgery
After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.
In the absence of fistula, the patient will reoperation for stoma closure of its branch

Study groups in NCT01876901
Study group	Role	What they receive
2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)	Experimental	Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. Receives: Procedure: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)
Colo-anal anastomosis (CAA)	Experimental	Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Receives: Procedure: Colo-anal anastomosis (CAA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA
Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma (curatively for 2-stage CA or prophylactic-based for CA). AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures.
Assuming an efficacy rates of 85% (null hypothesis) and 95% (alternative hypothesis), and relied on a superiority test at the 5% significance level (one-sided) with 80% power, 53 eligible and assessable patients were required. Efficacy of the intervention was concluded if at least 49 patients had no symptomatic AL at day 30.
Measured: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.

Secondary outcomes (8)

Stomata Bypass (Preventive or Therapeutic)
Number of patients with stomata bypass (preventive or therapeutic) at each time of follow-up after surgery (2SCA or CAA).
A stomata bypass is the result of a surgical operation in which a damaged part is removed from the ileum (ileostomy) or colon (colostomy) and the cut end diverted to an artificial opening in the abdominal wall.
Measured: Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA)
Post-operative Morbidity
Post-operative morbidity was assessed in terms number of patients with at least one surgical complications related to treatment and related to a serious adverse event.
Measured: During the 30 first days after surgery (2SCA or CAA)
Postoperative Mortality
Postoperative mortality was defined by the number of patients who deceased (all cause mortality) during the first 30 days after surgery (2SCA or CAA).
Measured: From the date of surgery to 30 days after surgery (2SCA or CAA)
Progression-free Survival
Progression-free survival (PFS) was defined as the time from the date of surgery and the date of the earliest of the following events:
- The patient's death, whatever the cause,
- Local progression or remotely.
Progression was defined as clinical or radioglogical progression. Radiological progression was defined Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
1-year and 2-year progression-free rates were estimated.
Measured: 1 and 2 years after surgery (2SCA or CAA)
Number of Participants With Anal Incontinence at 6 Months
The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20).
The rate of patients with anal incontinence (score >=5) at 6 months was reported.
Measured: At 6 months after surgery (2SCA or CAA)
Number of Participants With Anal Incontinence at 12 Months
The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20).
The rate of patients with anal incontinence (score >=5) at 12 months was reported.
Measured: At 12 months after surgery (2SCA or CAA)
Number of Participants With Anal Incontinence at 24 Months
The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20).
The rate of patients with anal incontinence (score >=5) at 24 months was reported.
Measured: At 24 months after surgery (2SCA or CAA)
Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA
Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma. AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures.
The effectiveness of the CAA surgery will be evaluated in terms of absence of fistula requiring stoma diversion. Similarly to 2SCA group, 53 CAA eligible and evaluable patients will be required. If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the CAA is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients CAA.
Measured: Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 201014 Feb 2019

First posted13 Jun 2013 (estimated)
Study start11 Aug 2010
Primary completion9 May 2017
Study completion14 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Medium and Lower Rectal CancerStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Two multicenter parallel single-arm phase II trials. One trial assessing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. One trial assessing colo-anal anastomosis (CAA) in centers who routinely performing this intervention.
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01876901
Sponsor's protocol ID: IB2010-08
Acronym: CASCADOR
Status last verified: Jul 2021
First submitted: 5 Nov 2012
Last updated: 4 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Evrard S, Bellera C, Desolneux G, Cantarel C, Toulza E, Faucheron JL, Rivoire M, Dupre A, Mabrut JY, Bresler L, Marchal F, Bouriez D, Rullier E. Anastomotic leakage and functional outcomes following total mesorectal excision with delayed and immediate colo-anal anastomosis for rectal cancer: Two single-arm phase II trials. Eur J Surg Oncol. 2023 Nov;49(11):107015. doi: 10.1016/j.ejso.2023.107015. Epub 2023 Oct 23.
PubMed 37949519

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.
ClinicalTrials.gov ID: NCT01876901
Acronym / sponsor ID: CASCADOR / IB2010-08
Conditions: Medium and Lower Rectal Cancer
Keywords: Rectal cancer, Coloanal anastomosis, Phase 2 clinical trial
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Institut BergoniéUniversity, hospital or other
Study start: 11 Aug 2010 (actual)
Primary completion: 9 May 2017 (actual)
Study completion: 14 Feb 2019 (actual)
First posted: 13 Jun 2013 (estimated)
Results: Posted 4 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis:

This study is a multicentre, two arms, phase 2 clinical trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Two multicenter parallel single-arm phase II trials. One trial assessing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. One trial assessing colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Arm	Type	Receives
2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)	Experimental	Procedure: 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.
Colo-anal anastomosis (CAA)	Experimental	Procedure: Colo-anal anastomosis (CAA)Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histologically proven rectal adenocarcinoma.
Medium or lower rectum tumour requiring removal of the entire rectum and its mesorectum.
T1 N+ or T2 N+ or T3 N+ or T3 N0 and M0 tumour.
Age between 18 and 75 years .
ASA ≤ 2.

Key exclusion criteria (7 listed)

Other histology of rectal cancer.
T1 N0 or T2 N0 or T4 tumour.
Metastatic disease M1.
History of cancer except cervix in situ carcinoma or skin basal cell carcinoma.
Patient with psychological, social, family or geographical reasons who couldn't be treated or monitored regularly by the criteria of the study

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
2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation	Procedure or surgery	2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)
Colo-anal anastomosis (CAA)After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch	Procedure or surgery	Colo-anal anastomosis (CAA)

Primary outcome

Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA
Time frame: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.
Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma (curatively for 2-stage CA or prophylactic-based for CA). AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. Assuming an efficacy rates of 85% (null hypothesis) and 95% (alternative hypothesis), and relied on a superiority test at the 5% significance level (one-sided) with 80% power, 53 eligible and assessable patients were required. Efficacy of the intervention was concluded if at least 49 patients had no symptomatic AL at day 30.

8 secondary outcomes

Stomata Bypass (Preventive or Therapeutic)
Time frame: Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA)
Post-operative Morbidity
Time frame: During the 30 first days after surgery (2SCA or CAA)
Postoperative Mortality
Time frame: From the date of surgery to 30 days after surgery (2SCA or CAA)
Progression-free Survival
Time frame: 1 and 2 years after surgery (2SCA or CAA)
Number of Participants With Anal Incontinence at 6 Months
Time frame: At 6 months after surgery (2SCA or CAA)
Number of Participants With Anal Incontinence at 12 Months
Time frame: At 12 months after surgery (2SCA or CAA)
Number of Participants With Anal Incontinence at 24 Months
Time frame: At 24 months after surgery (2SCA or CAA)
Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA
Time frame: Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.

Results and safety

Results posted to the registry on 4 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)	65	48
Colo-anal Anastomosis (CAA)	59	52

Primary outcome: Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA

Time frame: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.. Count of participants. Unit: Participants

Measure	2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) n = 48
Value	1

Population analysed: Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA)	30 of 48 (62.5%)	0 of 0	4 of 48
Colo-anal Anastomosis (CAA)	24 of 52 (46.2%)	0 of 0	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37949519Evrard S, Bellera C, Desolneux G, Cantarel C, Toulza E, Faucheron JL, Rivoire M, Dupre A, Mabrut JY, Bresler L, Marchal F, Bouriez D, Rullier E. Anastomotic leakage and functional outcomes following total mesorectal excision with delayed and immediate colo-anal anastomosis for rectal cancer: Two single-arm phase II trials. Eur J Surg Oncol. 2023 Nov;49(11):107015. doi: 10.1016/j.ejso.2023.107015. Epub 2023 Oct 23.
Individual participant dataSharing planned: No

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.

EVRARD Serge, PU-PH study chair

Institut Bergonié

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 7 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA (time frame: Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation.). 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 NCT01876901, 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 4 Sep 2025.