Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT01702116
Eligibility Criteria:
Inclusion Criteria:
* Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
* Stage T3 or T4 at MRI
* N0-2 at MRI
* M0 at CT scan
* Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents
Exclusion Criteria:
* Squamous cell carcinoma
* Adenocarcinoma Stage T1-2, any N
* T4 with one of the following:
with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01702116
Study Brief:
Protocol Section:
NCT01702116