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Trial registered on ANZCTR


Registration number
ACTRN12610000175077
Ethics application status
Approved
Date submitted
3/12/2009
Date registered
25/02/2010
Date last updated
19/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Preoperative Radiotherapy and Chemotherapy in patients with locally advanced rectal cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 09.01 - A Phase II Trial to assess the tolerability of Integrated Preoperative Radiotherapy and Chemotherapy with Oxaliplatin 5-Flurouracil (5-FU) and Folinic Acid in Patients with Locally Advanced Rectal Cancer
Secondary ID [1] 1168 0
ClinicalTrials.gov ID NCT01013805
Universal Trial Number (UTN)
Trial acronym
PROArCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Rectal Cancer 252336 0
Condition category
Condition code
Cancer 252525 252525 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Experimental - Integrated Preoperative Radiotherapy and chemotherapy.

Treatment: Other - Radiation Therapy. Weeks 3-5: radiotherapy 25.2Gy in 14 fractions over 3 weeks.
Weeks 8-10: radiotherapy 25.2Gy in 14 fractions over 3 weeks.

Treatment: drugs - Oxaliplatin. Week 1, Day 1: Administered 1st - Oxaliplatin 100mg/m2 (over 2 hours), leucovorin 200 mg/m2 day 1 concurrent with oxaliplatin over 2 hrs, given intravenously. Weeks 6 and 11 are the same as week 1.

Weeks 3-5: 85 mg/m2 Oxaliplatin, given intravenously, on first day of week 3. Weeks 8-10 are the same as weeks 3-5.

Treatment: drugs - Flurouracil.
Week 1, Day 1: Administered 2nd - 5-FU 400mg/m2 bolus, given intravenously.
Week 1 Day 1: Administered 3rd - 5-FU continuous infusion 2.4 g/m2, given intravenously, over 46 hours from Day 1. Weeks 6 and 11 are the same as week 1.

Weeks 3-5: Continuous 5-FU 200mg/m2/day, given intravenously, on days of radiotherapy. Weeks 8-10 are the same as weeks 3-5.

Treatment: drug - Leucovorin.
Week 1, Day 1: leucovorin 200mg/m2, given intravenously, Day 1 delivered concurrently with Oxaliplatin over 2 hours. Weeks 6 and 11 are the same as week 1.

Treatment: Surgery - 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.
Intervention code [1] 255644 0
Treatment: Other
Intervention code [2] 255645 0
Treatment: Drugs
Intervention code [3] 255646 0
Treatment: Surgery
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253407 0
Tolerability rate. Measured as the percentage of patients who are able to complete the planned treatment program and do no require a treatment break for toxicity.
Timepoint [1] 253407 0
End of preoperative treatment (11 weeks)
Secondary outcome [1] 262508 0
Complete pathologic response rate. measured as the conversion of clinical (Magnetic Resonance Imaging (MRI) staged) T3-4 (any N) to pathologic T (Tumour) 0 N (nodes) 0 in resected specimen following protocol treatment.
Timepoint [1] 262508 0
Post surgery
Secondary outcome [2] 262509 0
Toxicity Rates. Measured using the NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTC AE) v 3.0.
Timepoint [2] 262509 0
Determined following preoperative treatment and 30 days post-surgery
Secondary outcome [3] 262510 0
Dose intensity. Measured as Actual and relative dose intensity and Relative treatment duration of the FOLFOX regimen.
Timepoint [3] 262510 0
End or preoperative treatment (11 weeks)

Eligibility
Key inclusion criteria
Patients may be included in the trial only if they meet all of the following criteria
1. Previously untreated and pathologically proven adenocarcinoma of the rectum.
2. MRI staged T3 or T4, any N.
3. Lower border of tumour must be within 12 cm of anal verge.
4. Age = or > 18 years.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
6. Absolute neutrophil count > 1.5×109/L, haemoglobin > 90 g/L, and platelets > 100×109/L.
7. Adequate renal function: Glomerular Filtration Rate (GFR) > 55mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
8. Bilirubin and Alanine aminotransferase (ALT) < or = 1.5 x upper limit of normal.
9. No symptomatic peripheral neuropathy > grade 2.
10. Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
11. Has provided written informed consent for participation in this trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who fulfill any of the following criteria are not eligible for admission to the trial:

1. Presence of metastatic disease.
2. Prior pelvic radiotherapy
3. Febrile intercurrent illness or infection.
4. Previous history of unstable angina
5. Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
6. Acute coronary syndrome even if controlled with medication
7. Myocardial infarction within the last 12 months
8. Concurrent treatment with other anti-cancer therapy.
9. 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.
10. Locally recurrent rectal cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to patient enrolment, the investigator should ensure that all of the following requirements are met:
1. The patient meets all inclusion criteria and none of the exclusion criteria should apply.
2. The patient has signed and dated all applicable consent forms.
3. All baseline assessments and investigations have been performed.
4. The eligibility checklist has been completed, signed and dated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/04/2010
Actual
9/04/2010
Date of last participant enrolment
Anticipated
Actual
25/07/2012
Date of last data collection
Anticipated
Actual
28/02/2014
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 4711 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 4712 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [3] 4713 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 4714 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 4715 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 4716 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 256125 0
Other Collaborative groups
Name [1] 256125 0
Trans Tasman Radiation Oncology Group (TROG)
Country [1] 256125 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Central Operations Office
Calvary Mater Newcastle
Locked Bag 7 HRMC
NSW 2310
Country
Australia
Secondary sponsor category [1] 251467 0
Individual
Name [1] 251467 0
Assoc. Prof Sam Ngan
Address [1] 251467 0
Division of Radiation Oncology
Peter MacCallum Cancer Centre
1 St Andrews Place
East Melbourne, Victoria, 3002
Country [1] 251467 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258216 0
Peter MacCallum Ethics Committee
Ethics committee address [1] 258216 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [1] 258216 0
Australia
Date submitted for ethics approval [1] 258216 0
Approval date [1] 258216 0
26/05/2009
Ethics approval number [1] 258216 0
9/12/2009

Summary
Brief summary
This study looks at the effectiveness and tolerability of integrated radiotherapy and chemotherapy with oxaliplatin 5-flurouracil (5-fu) and folinic acid before surgery in patients with locally advanced adenocarcinoma of the rectum (back passage).

Who is it for?
You can join this study if you have locally advanced cancer of the rectum (back passage) which you have not yet received treatment for.

Trial details
Participants will receive integrated preoperative radiotherapy with FOLFOX chemotherapy over 11 weeks, prior to standard surgery 4-6 weeks later . Patients will be monitored to determine their tolerance and response to treatment.
Trial website
www.trog.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30576 0
Prof Sam Ngan
Address 30576 0
Division of Radiation Oncology
Peter MacCallum Cancer Centre
1 St Andrews Place
East Melbourne, Victoria, 3002
Country 30576 0
Australia
Phone 30576 0
+61 3 9656 1111
Fax 30576 0
Email 30576 0
[email protected]
Contact person for public queries
Name 13823 0
Bev McClure
Address 13823 0
Centre for Biostatistics and Clinical Trials (BaCT) Peter MacCallum Cancer Centre 1 St Andrews Place East Melbourne, Victoria, 3002
Country 13823 0
Australia
Phone 13823 0
+61 3 9656 1266
Fax 13823 0
+61 3 9656 1420
Email 13823 0
[email protected]
Contact person for scientific queries
Name 4751 0
Bev McClure
Address 4751 0
Centre for Biostatistics and Clinical Trials (BaCT) Peter MacCallum Cancer Centre
1 St Andrews Place
East Melbourne, Victoria, 3002
Country 4751 0
Australia
Phone 4751 0
+61 3 9656 1266
Fax 4751 0
+61 3 9656 1420
Email 4751 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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