Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013805
• Other study ID #: TROG 09.01
• Secondary ID: ACTRN12610000175
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2009
• Last updated: July 10, 2017
• Start date: November 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2017
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

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.
• 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
• 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.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen		End of preoperative treatment (11 weeks)
Secondary	Complete pathologic response rate following the completion of treatment		Determined post-surgery
Secondary	Treatment Related Toxicity rates		Determined after preoperative treatment and 30 days post-surgery
Secondary	Dose Intensity of the treatment drug		End of preoperative treatment (11 weeks)

External Links

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