N/A
N=350
Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Neoplasm, Rectum
Bottom Line
View on ClinicalTrials.gov: NCT03287843 ↗Enrolled (actual)
350
Serious AEs
21.1%
Results posted
Aug 2019
Primary outcome: Primary: Pathological Complete Response Rate — 16; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Total mesorectal excision before 56 days (4-8 weeks) (Procedure); Total mesorectal excision after 56 days (8-12 weeks) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ege University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathological Complete Response Rate |
16; 31 | — |
| SECONDARY Completeness of the Mesorectal Dissection |
5; 8; 11; 10; 144; 149 | — |
| SECONDARY Tumour Regression Grade |
16; 31; 37; 36; 73; 67 | — |
| SECONDARY Surgical Complications |
4; 7; 15; 14; 4; 3 | — |
| SECONDARY Recurrence |
— | — |
| SECONDARY Disease-free Survival |
— | — |
| SECONDARY Overall Survival |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease )
- Patients with histologically confirmed adenocarcinoma of the rectum
- Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy)
- Standardized total mesorectal excision surgery
- Tumor must be clinically resectable with curative intent (R0 resection must be most likely)
- Elective operation
- The patient must consent to be in the study and the informed consent must be signed
Exclusion Criteria
- Clinic stage I and IV cancer disease
- Patients with malignant disease of the rectum other than adenocarcinoma
- Recurrent rectal cancer
- Emergency cases (Mechanical bowel obstruction, perforation)
- Other previous or concurrent malignancies
- Any contraindication for radiochemotherapy
- Previous chemotherapy or radiotherapy to the pelvis
- Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease
- American Society of Anesthesiologists Score >3 patients
Data sourced from ClinicalTrials.gov (NCT03287843). 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.