Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

NCT01013805 | Completed Phase 2

• 2 other identifiers: TROG 09.01ACTRN12610000175077
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

Rectal Cancer; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

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

  End of preoperative treatment (11 weeks)

Secondary Outcomes (3)

• Complete pathologic response rate following the completion of treatment

  Determined post-surgery

• Treatment Related Toxicity rates

  Determined after preoperative treatment and 30 days post-surgery

• Dose Intensity of the treatment drug

  End of preoperative treatment (11 weeks)

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Radiation: External Beam Radiotherapy; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin; Procedure: Surgical Resection

Interventions

External Beam Radiotherapy 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

Also known as: Radiotherapy, RT

Arm 1

Oxaliplatin 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.

Arm 1

Fluorouracil 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

Arm 1

Leucovorin 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.

Arm 1

Surgical Resection 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.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Related Links

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

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Sam Ngan

  Trans Tasman Radiation Oncology Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: November 16, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

AU (1)