Chemoradiotherapy plus avelumab in locally advanced rectal cancer
- Conditions
- ocally advanced rectal cancerMedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003582-10-IT
- Lead Sponsor
- G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 101
Locally advanced, resectable disease defined by the presence of at least one of the following features:
cN+, cT4, high risk cT3 (according to magnetic resonance imaging [MRI] criteria);
distal tumor margin at < 12 cm from the anal verge;
no evidence of metastatic disease by computed tomography (CT) scan of the chest and abdomen and total body FDG-PET/CT scan;
tumor must be amenable to curative resection;
no history of invasive rectal malignancy;
no other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer;
available tumor samples at baseline (archival biopsy) and after chemoradiotheraphy + avelumab.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61
Previous therapy with any antibody or drug targeting T cell coregulatory proteins, or immunosuppressive agents;
previous pelvic RT;
active autoimmune disease;
current use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroids injection (e.g. intra- articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent, steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);
prior organ transplantation;
known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening;
vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the rate of complete pathologic response (pCR);Secondary Objective: R0 resection rate; Tumor downstaging; Local recurrence; Sphincter preservation rate; Progression-free survival (PFS); Overall survival (OS); Safety profile; Evaluation of exploratory predictive and/or prognostic biomarkers.;Primary end point(s): Pathologic Complete Response (pCR) Rate.<br>pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects, achieving complete histological regression with no available tumor cells yT0N0 (a central pathology review will be performed at Istituto Nazionale Tumori di Milano).;Timepoint(s) of evaluation of this end point: 48 month
- Secondary Outcome Measures
Name Time Method