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Completed

NCT Number: NCT00263029

Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer

The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ECOG performance status score 0-1.
  • Chemo-naïve patients.
  • Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.
  • Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.
  • Adequate haematological, renal and liver functions as follows:
  • ANC > 3000ml
  • Platelet count > 100,000 ml
  • Urea & Serum Creatinine < 1.5 X upper limit of normal value
  • Total serum bilirubin < 1.5 X upper limit of normal value
  • ALT & AST < 3 X upper limit of normal value

Exclusion criteria

  • Prior chemotherapy.
  • Documented allergy to oxaliplatin or capecitabine.
  • Prior radiotherapy to pelvis.
  • Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
  • Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
  • Currently participating into another clinical trial with any investigational drug in the previous 30 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Oxaliplatin

Drug

60mg/m² as a 2-hour intravenous infusion every week for 5-6 week

Capecitabine

Drug

500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart

Radiotherapy

Radiation

Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions

Primary outcomes

  1. Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).

    Time frame: 3-years disease- free-survival or 3-years overall survival

Secondary outcomes

  1. Adverse events collection

    Time frame: From the signature of the informed consent up to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)

Acronym: PROCTFUL

Important dates

Study start
2002
Primary completion
2007
First posted
Dec 7, 2005
Registry last updated
Sep 18, 2009

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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