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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT01013805
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated and pathologically proven adenocarcinoma of the rectum.
* MRI staged T3 or T4, any N.
* Lower border of tumour must be within 12 cm of anal verge.
* Age greater than or equal to 18 years.
* ECOG Performance Status 0-1 (Appendix 2)
* Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L.
* Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
* Bilirubin and ALT less than or equal to 1.5 x upper limit of normal.
* No symptomatic peripheral neuropathy greater than or equal to grade 2.
* Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
* Has provided written informed consent for participation in this trial
Exclusion Criteria:
* Presence of metastatic disease.
* Prior pelvic radiotherapy
* Febrile intercurrent illness or infection.
* Previous history of unstable angina
* Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
* Acute coronary syndrome even if controlled with medication
* Myocardial infarction within the last 12 months
* Concurrent treatment with other anti-cancer therapy.
* Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
* Locally recurrent rectal cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01013805
Study Brief:
Protocol Section:
NCT01013805