Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01013805
• Date of registration: 08/10/2009
• Primary sponsor: Trans-Tasman Radiation Oncology Group (TROG)
• Public title: Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer PROArCT
• Scientific title: A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer
• Date of first enrolment: November 2009
• Target sample size: 40
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01013805
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia

Contacts

• Name: Sam Ngan

• Name: Bev McClure

• Name: Sam Ngan
• Affiliation: Trans-Tasman Radiation Oncology Group (TROG)

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rectal Cancer

Intervention(s)

Drug: Fluorouracil

Drug: Leucovorin

Drug: Oxaliplatin

Procedure: Surgical Resection

Radiation: External Beam Radiotherapy

Primary Outcome(s)

Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen [Time Frame: End of preoperative treatment (11 weeks)]

Secondary Outcome(s)

Complete pathologic response rate following the completion of treatment [Time Frame: Determined post-surgery]

Dose Intensity of the treatment drug [Time Frame: End of preoperative treatment (11 weeks)]

Treatment Related Toxicity rates [Time Frame: Determined after preoperative treatment and 30 days post-surgery]

Secondary ID(s)

TROG 09.01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors