Clinical trial NCT03607370: Timing for Rectal Surgery After Chemoradiotherapy
Official title: Timing for Rectal Surgery After ChST
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
Chemoradiotherapy
Surgery
Lead sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 8 weeks.

Hypothesis: Greater down-staging and tumor regression is observed when surgery is delayed to 12 weeks after completion of chemoradiotherapy compared to 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Eastern Cooperative Oncology Group (ECOG) 0-1,
* American Society of Anesthesiologists' (ASA) score I-III
* Histological confirmation of adenocarcinoma of rectum
* T3 or T4 N0, T any N positive cancer on MRI, without metastasis on CT scan
* Undergoing preoperative radiotherapy/ chemotherapy
* Curative total mesorectal excision intended
* Written informed consent
* Patients undergoing preoperative radiotherapy should not be excluded

Exclusion Criteria:

* Patients with distant metastasis
* T1 or T2, N0 cancer on MRI
* Rectal cancer 12 cm above the dentate line
* Contraindications to MRI
* Patients previously treated of pelvic organ cancer
* Medical or psychiatric conditions that compromise the patients ability to give informed consent

Primary outcomes:
measure: Complete pathologic response assessed by pathologist Dworak scale
timeFrame: 6 months
Secondary outcomes:
measure: Clinical response assessed using MRi
timeFrame: 8 weeks (2 months)
measure: Pathological response assessed by pathologist using Dworak scale
timeFrame: 6 months
measure: Incidence of Treatment-Emergent Adverse Events as assessed by Clavien-Dindo scale
timeFrame: 30 days
measure: Incidence of Mortality assessed by Clavien-Dindo scale
timeFrame: 30 days
measure: Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke)
timeFrame: 8-12 weeks
measure: Distant recurrence assessed by CT scan
timeFrame: 5 years
measure: Local recurrence assessed by CT scan/MRI/endoscopy
timeFrame: 5 years
measure: Oncological outcome - overall survival
timeFrame: 5 years
measure: Oncological outcome - disease-free survival
timeFrame: 5 years
measure: Radiotherapy skin toxicity assessed by EORTC scale
timeFrame: 5 years
measure: Radiotherapy toxicity assessed by EORTC scale
timeFrame: 5 years
measure: Quality of Life assessed by Low anterior resection syndrome score
timeFrame: 1 year
measure: Immune response assessed
timeFrame: 1 year
measure: Urinary catheter removal timing
timeFrame: 3 months
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Audrius Dulskas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: