Preoperative Radiotherapy and Chemotherapy in patients with locally advanced rectal cancer

Phase 2

Completed

• Conditions: ocally Advanced Rectal Cancer; Locally Advanced Rectal Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12610000175077
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients may be included in the trial only if they meet all of the following criteria
1. Previously untreated and pathologically proven adenocarcinoma of the rectum.
2. MRI staged T3 or T4, any N.
3. Lower border of tumour must be within 12 cm of anal verge.
4. Age = or > 18 years.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
6. Absolute neutrophil count > 1.5×109/L, haemoglobin > 90 g/L, and platelets > 100×109/L.
7. Adequate renal function: Glomerular Filtration Rate (GFR) > 55mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
8. Bilirubin and Alanine aminotransferase (ALT) < or = 1.5 x upper limit of normal.
9. No symptomatic peripheral neuropathy > grade 2.
10. Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
11. Has provided written informed consent for participation in this trial

Exclusion Criteria

Patients who fulfill any of the following criteria are not eligible for admission to the trial:

1. Presence of metastatic disease.
2. Prior pelvic radiotherapy
3. Febrile intercurrent illness or infection.
4. Previous history of unstable angina
5. Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
6. Acute coronary syndrome even if controlled with medication
7. Myocardial infarction within the last 12 months
8. Concurrent treatment with other anti-cancer therapy.
9. 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.
10. Locally recurrent rectal cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability rate. Measured as the percentage of patients who are able to complete the planned treatment program and do no require a treatment break for toxicity.[End of preoperative treatment (11 weeks)]

Secondary Outcome Measures

Name	Time	Method
Complete pathologic response rate. measured as the conversion of clinical (Magnetic Resonance Imaging (MRI) staged) T3-4 (any N) to pathologic T (Tumour) 0 N (nodes) 0 in resected specimen following protocol treatment.[Post surgery];Toxicity Rates. Measured using the NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTC AE) v 3.0.[Determined following preoperative treatment and 30 days post-surgery];Dose intensity. Measured as Actual and relative dose intensity and Relative treatment duration of the FOLFOX regimen.[End or preoperative treatment (11 weeks)]