Phase 2
N=124
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Medium and Lower Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01876901 ↗Enrolled (actual)
124
Serious AEs
54.0%
Results posted
Aug 2021
Primary outcome: Primary: Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) (Procedure); Colo-anal anastomosis (CAA) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA |
1 | — |
| SECONDARY Stomata Bypass (Preventive or Therapeutic) |
2; 49; 3; 3; 6; 8 | — |
| SECONDARY Post-operative Morbidity |
13; 10 | — |
| SECONDARY Postoperative Mortality |
0; 0 | — |
| SECONDARY Progression-free Survival |
76.5; 92.2; 63.3; 81.3 | — |
| SECONDARY Number of Participants With Anal Incontinence at 6 Months |
25; 32 | — |
| SECONDARY Number of Participants With Anal Incontinence at 12 Months |
15; 36 | — |
| SECONDARY Number of Participants With Anal Incontinence at 24 Months |
11; 29 | — |
| SECONDARY Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA |
5 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01876901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.