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

Primary Purpose

Rectal Cancer

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

External Beam Radiotherapy

Oxaliplatin

Fluorouracil

Leucovorin

Surgical Resection

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Chemotherapy, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
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.

Sites / Locations

Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complete pathologic response rate following the completion of treatment

Treatment Related Toxicity rates

Dose Intensity of the treatment drug

Full Information

NCT ID

NCT01013805

First Posted

October 8, 2009

Last Updated

July 10, 2017

Sponsor

Trans Tasman Radiation Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT01013805

Brief Title

Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

Acronym

PROArCT

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Trans Tasman Radiation Oncology Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

Rectal Cancer, Chemotherapy, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.

Intervention Type

Radiation

Intervention Name(s)

External Beam Radiotherapy

Other Intervention Name(s)

Radiotherapy, RT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Surgical Resection

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

End of preoperative treatment (11 weeks)

Secondary Outcome Measure Information:

Title

Complete pathologic response rate following the completion of treatment

Time Frame

Determined post-surgery

Title

Treatment Related Toxicity rates

Time Frame

Determined after preoperative treatment and 30 days post-surgery

Title

Dose Intensity of the treatment drug

Time Frame

End of preoperative treatment (11 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam Ngan

Organizational Affiliation

Trans Tasman Radiation Oncology Group

Official's Role

Study Chair

Facility Information:

Facility Name

Peter MacCallum Cancer Centre

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

8006

Country

Australia

12. IPD Sharing Statement

Links:

URL

http://www.trog.com.au

Description

Click here for more information about this study on the TROG website

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Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

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