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A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

Thank you

Trial Information

A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen

Outcome Time Frame:

End of preoperative treatment (11 weeks)

Safety Issue:

Yes

Principal Investigator

Sam Ngan

Investigator Role:

Study Chair

Investigator Affiliation:

Trans-Tasman Radiation Oncology Group (TROG)

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 09.01

NCT ID:

NCT01013805

Start Date:

November 2009

Completion Date:

October 2012

Related Keywords:

  • Rectal Cancer
  • Rectal Cancer
  • Chemotherapy
  • Radiotherapy
  • Rectal Neoplasms

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