Status:
UNKNOWN
Predictors of Normal Tissue Response From the Microenvironment in Radiotherapy for Prostate and Head-and-neck Cancer
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Prostate Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The main idea behind MICRO-LEARNER is to provide new insights about the response of healthy tissues to radiation by using information from the micro-environment obtained by biological measurements and...
Detailed Description
\*\*Prospective Clinical Trial: discovery population\*\* 130 PCa and 130 HNCa consecutive patients will be enrolled in 18 months. All patients will receive radiotherapy at radical curative doses at t...
Eligibility Criteria
Inclusion
- Inclusion Criteria (PCa patients in discovery and validation cohorts):
- Patients with histologically confirmed diagnosis of PCa candidate to exclusive or post-surgical radiotherapy, in both case it can be associated to hormone therapy
- Prognostic risk included in the very low, low, intermediate or high risk classes following the NCCN Clinical Practice Guidelines in Oncology and patients with oligometastatic disease treated with curative doses to the prostate (≥70 Gy at 2 Gy per fraction)
- Written informed consent to the study
- Exclusion Criteria (PCa patients in discovery and validation cohorts):
- Previous pelvic radiotherapy
- Autoimmune disease (scleroderma,Chron's disease and ulcerative colitis), chronic kidney disease requiring dyalis
- Patients with malignant neoplasm in treatment with local or systemic therapies, except for patients with PCa and skin cancers
- Refusal to accept the study participation modalities
- Inclusion Criteria (HNCa patients in discovery and validation cohorts):
- ECOG PS ≤ 3
- Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck (oral cavity, pharynx, larynx, paranasal sinuses and nasal cavity, salivary glands)
- Non-metastatic stage III-IV cancer of the pharinx, larynx according to AJCC VII edition. Patients with stage III-IV cancer of salivary glands o paranasal sinuses. Patients with stage I-II cancer of pharinx and larynx only if neck lymph nodes or oral mucosa are included in the irradiated volume
- Indication to exclusive or post-surgical radiotherapy (associated or not to systemic therapy according to internal guidelines)
- Written informed consent to the study
- Exclusion Criteria (HNCa patients in discovery and validation cohorts):
- Previous head and neck radiotherapy
- Connective tissue disease (lupus erythematosus or scleroderma) or other concomitant head and neck cancers, except for in situ skin cancers not requiring radiotherapy or systemic therapies.
- Refusal to accept the study participation modalities
Exclusion
Key Trial Info
Start Date :
February 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03294122
Start Date
February 2 2017
End Date
December 31 2019
Last Update
October 3 2017
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy, 20133