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Completed

NCT Number: NCT01013805

Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Radiotherapy, RT

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.

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

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.

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.

Primary outcomes

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

    Time frame: End of preoperative treatment (11 weeks)

Secondary outcomes

  1. Complete pathologic response rate following the completion of treatment

    Time frame: Determined post-surgery

  2. Treatment Related Toxicity rates

    Time frame: Determined after preoperative treatment and 30 days post-surgery

  3. Dose Intensity of the treatment drug

    Time frame: End of preoperative treatment (11 weeks)

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Registry information

Official study 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

Acronym: PROArCT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2009
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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