Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer (PROArCT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01013805
First received: October 8, 2009
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Radiation: External Beam Radiotherapy
Drug: Oxaliplatin
Drug: Fluorouracil
Drug: Leucovorin
Procedure: Surgical Resection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen [ Time Frame: End of preoperative treatment (11 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete pathologic response rate following the completion of treatment [ Time Frame: Determined post-surgery ] [ Designated as safety issue: No ]
  • Treatment Related Toxicity rates [ Time Frame: Determined after preoperative treatment and 30 days post-surgery ] [ Designated as safety issue: Yes ]
  • Dose Intensity of the treatment drug [ Time Frame: End of preoperative treatment (11 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: November 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.
Radiation: External Beam Radiotherapy

Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy.

Weeks 8-10: as per Weeks 3-5

Other Names:
  • Radiotherapy
  • RT
Drug: Oxaliplatin

Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU).

Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.

Drug: Fluorouracil

Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.

Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.

Leucovorin 200 mg/m2 Day 1 concurrent with Oxaliplatin over 2 hrs, then 2nd: 5-FU 400 mg/m2 bolus Day 1, then 3rd: 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1

Drug: Leucovorin
Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
Procedure: Surgical Resection
Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013805

Locations
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Study Chair: Sam Ngan Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT01013805     History of Changes
Other Study ID Numbers: TROG 09.01, ACTRN12610000175077
Study First Received: October 8, 2009
Last Updated: July 30, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Rectal Cancer
Chemotherapy
Radiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014