Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

NCT ID: NCT01013805

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

External Beam Radiotherapy

Intervention Type: RADIATION

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

Oxaliplatin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Surgical Resection

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: RADIATION

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

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 Type: PROCEDURE

Other Intervention Names

Radiotherapy; RT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Ngan

Role: STUDY_CHAIR

Trans Tasman Radiation Oncology Group

Locations

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Countries

Australia

Related Links

http://www.trog.com.au

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

Other Identifiers

ACTRN12610000175077

Identifier Type: REGISTRY

Identifier Source: secondary_id

TROG 09.01

Identifier Type: -

Identifier Source: org_study_id