Timing for Rectal Surgery After Chemoradiotherapy (ST812)

National Cancer Institute, Lithuania

Status

Active, not recruiting

Conditions

Rectal Cancer

Treatments

Procedure: Surgery after 12 weeks of delay after chemoradiotherapy.

Study type

Interventional

Funder types

Other

Identifiers

NCT03607370

ST812

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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