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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01013805




Trial ID
NCT01013805
Ethics application status
Date submitted
8/10/2009
Date registered
13/11/2009
Date last updated
10/07/2017

Titles & IDs
Public title
Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer
Scientific 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
Secondary ID [1] 0 0
ACTRN12610000175077
Secondary ID [2] 0 0
TROG 09.01
Universal Trial Number (UTN)
Trial acronym
PROArCT
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - External Beam Radiotherapy
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Surgery - Surgical Resection

Experimental: Arm 1 - Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.


Treatment: Other: 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

Treatment: Drugs: 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.

Treatment: Drugs: 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

Treatment: Drugs: 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.

Treatment: Surgery: 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.

Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen
Timepoint [1] 0 0
End of preoperative treatment (11 weeks)
Secondary outcome [1] 0 0
Complete pathologic response rate following the completion of treatment
Timepoint [1] 0 0
Determined post-surgery
Secondary outcome [2] 0 0
Treatment Related Toxicity rates
Timepoint [2] 0 0
Determined after preoperative treatment and 30 days post-surgery
Secondary outcome [3] 0 0
Dose Intensity of the treatment drug
Timepoint [3] 0 0
End of preoperative treatment (11 weeks)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
8006 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Trans-Tasman Radiation Oncology Group (TROG)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01013805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Ngan
Address 0 0
Trans-Tasman Radiation Oncology Group (TROG)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries