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Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

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

NCT01013805•Trans Tasman Radiation Oncology Group

View on ClinicalTrials.gov

Summary

The aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Key Dates

Start Date

November 1, 2009

Primary Completion Date

December 1, 2012

Completion Date

December 1, 2012

Last Updated

July 12, 2017

Enrollment

ACTUAL participants

Conditions

Rectal Cancer

Interventions

External Beam Radiotherapy

RADIATION

Oxaliplatin

DRUG

Fluorouracil

DRUG

Leucovorin

DRUG

Surgical Resection

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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