A Phase 2 interventional study of RADIOTHERAPY and PANITUMUMAB in Carcinoma of Anal Canal, sponsored by Centre Hospitalier Universitaire Vaudois. Terminated at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-19.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 2, Interventional, and Treatment
There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial investigates concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy. Treatment components used in this study have been selected on scientific rationale. The trial regimen should be feasible with acceptable toxicity and outcome similar to historic series.
OBJECTIVES:
Primary:
-To assess efficacy of treatment regimen composed of capecitabine, mitomycin, panitumumab, and radiotherapy in terms of locoregional control rate in patients with stage II-IIIB squamous-cell carcinoma of the anal canal.
Secondary:
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 8 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to registration.
Exclusion Criteria:
RADIOTHERAPY: daily fraction dose of 1.8Gy , 5 days a week between day 1 and 45 Intensity modulated radiotherapy (IMRT), using a linac based facility or helical tomotherapy, is obligatory. The first treatment sequence consists of a total dose of 36 Gy in 20 daily fractions of 1.8 Gy on five days a week. The second treatment sequence consists of a total dose of 23.4 Gy in 13 daily fractions of 1.8 Gy on five days a week. PANITUMUMAB: 6 mg/kg IV over 60 min infusion on days 1, 15 and 29 MITOMYCIN: 10 mg/m2 IV over 15 min infusion on days 1 and 29 CAPECITABINE: 825 mg/m2 oral twice daily on days 1 to 45
Radiation: RADIOTHERAPY · Biological: PANITUMUMAB · Drug: MITOMYCIN · Drug: CAPECITABINE
External beam radiotherapy (daily fraction dose 1.8Gy) on Monday through Friday starting on study day 1. * Days 1-28, dose of 36 Gy in 1.8 Gy/fraction (20 fractions) to the clinical target volume 1 (CTV1) including the primary tumor and involved lymph nodes and areas at risk for metastatic spread (which includes gross tumour volumes (GTV) and a 1-cm expansion, mesorectal space, inguinal, femoral, external iliac, internal iliac, and common iliac vessels). * Days 29-45, a boost dose of 23.4 Gy in 1.8 Gy/fraction (13 fractions) to the GTV.
6 mg/kg IV administered over 60 min infusion on days 1,15 and 29.
10 mg/m2 IV administered over 15 min infusion on days 1 and 29.
825mg/m2 orally twice daily on study days 1 through 45.
Efficacy
Time frame: 2-year locoregional control in patients, which is defined as the absence of locoregional recurrence 2 years after treatment start.
Complete response (CR) rate
Tumor assessment will be done by the investigator according to the RECIST 1.1. criteria.
Time frame: 5 years
Colostomy-free survival
2-year colostomy-free survival (patients without colostomy two-years after treatment start).
Time frame: 2 and 5 years
Functional colostomy-free survival
2-year functional colostomy-free survival (patients without colostomy and without stool incontinence or other sphincter symptoms interfering with activities of daily life two years after treatment start, which correspond to grade 3 toxicity according to common toxicity criteria National Cancer Institute-Common Toxicity Criteria for Adverse Event (NCI-CTCAE) version 4.0.
Time frame: 2 and 5 years
Overall survival (OS)
2-year overall survival (proportion of patients alive two years after treatment start) and median overall survival (median of the interval (days) between treatment start and death for any cause).
Time frame: 2 and 5 years
Progression-free survival (PFS)
2-year PFS (proportion of patients progression-free two years after treatment start) and median PFS according to the RECIST 1.1 criteria. PFS is defined as the interval (days) between registration and the date of progression (based on the actual tumor assessment date), or death for any cause, whichever comes first. The death of a patient without a reported progression will be considered as an event on the date of death. Patients who have neither progressed nor died will be censored on the date of last evaluable tumor assessment. Patients who had no post-baseline assessments and did not have an event will be censored at the time of registration.
Time frame: 2 and 5 years
Tolerability and safety profile of this regimen.
Toxicities will be assessed according to the NCI-CTCAE (version 4.0).
Time frame: Early (6 weeks after treatment) and late (up to 2 and 5 years after treatment).
Role of PET for staging and outcome prediction.
Predictive value of PET for PFS. Comparison of PET for determination of complete response with radiologic response and clinical response.
Time frame: 5 years
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire Vaudois