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Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
NA trial testing Total mesorectal excision before 56 days (4-8 weeks) in Neoplasm, Rectum in 350 participants. Completed in 1 January 2022.
| Lead sponsor | Ege University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 350 |
| Start date | 1 January 2006 |
| Primary completion | 1 January 2017 |
| Estimated completion | 1 January 2022 |
Ege University
Adults 18 to 85, any sex, with Neoplasm, Rectum. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete pathological response, defined as the absence of viable tumor cells, may develop after neoadjuvant treatment for rectal cancer. Prognostic factors affecting pathological complete response will be evaluated.
| Group | Value | 95% CI |
|---|---|---|
| Classic Interval Group | 16 | |
| Long Interval Group | 31 |
Examination will be made in a fresh state for completeness of the mesorectal dissection and will be graded according to the criteria of Quirke as follows: Low: (Grade 1) Little bulk of the mesorectum with defects down into the muscularis propria and/or very irregular circumferential resection margin. Moderate: (Grade 2) Moderate bulk of the mesorectum but there is irregularity in the mesorectal surface. Moderate coning of the specimen toward the distal margin. At no site is the muscularis propria visible with exception of the insertion of the levator muscles. Moderate irregularity of the cir
| Group | Value | 95% CI |
|---|---|---|
| Classic Interval Group | 5 | |
| Long Interval Group | 8 | |
| Classic Interval Group | 11 | |
| Long Interval Group | 10 | |
| Classic Interval Group | 144 | |
| Long Interval Group | 149 |
All pathological examinations were undertaken by two experienced gastrointestinal pathologists. Pathological treatment response to neoadjuvant chemoradiotherapy was evaluated by a five-tiered system described by Mandard. Tumor regression grade groups were identified as: Grade 1: the absence of residual cancer Grade 2: the presence of residual cancer cells scattered throughout the fibrosis Grade 3: an increase in the number of residual cancer cells but fibrosis still predominant Grade 4: residual cancer outgrowing fibrosis Grade 5, the absence of regressive changes Grade 1 considered as comp
| Group | Value | 95% CI |
|---|---|---|
| Classic Interval Group | 16 | |
| Long Interval Group | 31 | |
| Classic Interval Group | 37 | |
| Long Interval Group | 36 | |
| Classic Interval Group | 73 | |
| Long Interval Group | 67 | |
| Classic Interval Group | 31 | |
| Long Interval Group | 29 |
Morbidity will be assessed according to the classification of Clavien-Dindo as follows: Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition
| Group | Value | 95% CI |
|---|---|---|
| Classic Interval Group | 4 | |
| Long Interval Group | 7 | |
| Classic Interval Group | 15 | |
| Long Interval Group | 14 | |
| Classic Interval Group | 4 | |
| Long Interval Group | 3 | |
| Classic Interval Group | 8 | |
| Long Interval Group | 2 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Classic Interval Group | Long Interval Group |
|---|---|---|---|
| Wound infection | Surgical and medical procedures | — | — |
| Prerenal insufficiency | Renal and urinary disorders | — | — |
| Mechanical bowel obstruction | Gastrointestinal disorders | — | — |
| Anastomotic leakage | Gastrointestinal disorders | — | — |
| Other | Surgical and medical procedures | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Urinary tract infectio | Renal and urinary disorders | — | — |
| Pelvic abscess | Infections and infestations | — | — |
| Postoperative bleeding | Surgical and medical procedures | — | — |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | — | — |
| Deep vein thrombosis, pulmonary embolism | Vascular disorders | — | — |
| Urinary leakage | Renal and urinary disorders | — | — |
Most-reported serious reactions: Wound infection, Prerenal insufficiency, Mechanical bowel obstruction, Anastomotic leakage, Other, Pneumonia, Urinary tract infectio, Pelvic abscess.
Data from ClinicalTrials.gov NCT03287843 adverse events section.
This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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