Study Stopped
Toxicity and lack of efficacy
Radiation Therapy, Chemotherapy, and Cetuximab Followed by Surgery, Chemotherapy, and Cetuximab in Treating Patients With Locally Advanced or Metastatic Rectal Cancer That Can Be Removed by Surgery
Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous Locally Advanced or Metastatic Cancers of the Rectum With Metastases Resectable From the Start (T3-4 Nx or T2 N+ M1).
4 other identifiers
interventional
19
1 country
10
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 colorectal-cancer
Started Oct 2007
Shorter than P25 for phase_2 colorectal-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedStudy Start
First participant enrolled
October 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2010
CompletedFebruary 11, 2020
February 1, 2020
2.3 years
October 5, 2007
February 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete remission at ≥ 6 months by abdomino-pelvic-thoracic scan and a pelvic MRI
Secondary Outcomes (13)
Preoperative clinical response
Progression-free survival
Overall survival
Early toxicity before surgery
Early toxicity due to surgery (mortality at 30 days, postoperative complications, surgical recovery)
- +8 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- ECOG performance status 0-2
- WBC ≥ 4,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 130 µmol/L
- Transaminases ≤ 5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients of must use effective contraception
You may not qualify if:
- Contraindication to therapy with capecitabine, oxaliplatin, cetuximab, and/or radiotherapy
- Impossible to perform translational analyses
- Uncontrolled severe illness
- Severe renal or hepatic insufficiency
- Cardiac insufficiency or symptomatic coronary disease
- Sensitive peripheral neuropathy
- Uncontrolled diabetes
- Other malignancy within the past 10 years except previously treated basal cell skin cancer or carcinoma in situ of the cervix
- Impossible to participate in study due to geographic, social, or psychiatric reasons
- Patients who are under supervision or incarcerated
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior anticancer chemotherapy or radiotherapy for this cancer
- No therapy with coumarin anticoagulants, phenytoin, sorivudine, brivudine, antacids, or allopurinol
- No concurrent participation in another therapeutic study or receiving another experimental drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (10)
Institut Bergonie
Bordeaux, 33076, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Rene Huguenin
Saint-Cloud, 92210, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, F-94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Azria, MD, PhD
Institut du Cancer de Montpellier - Val d'Aurelle
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
October 29, 2007
Primary Completion
January 29, 2010
Study Completion
January 29, 2010
Last Updated
February 11, 2020
Record last verified: 2020-02