EUCTR2006-003381-33-SI
Active, not recruiting
Not Applicable
Induction chemotherapy followed by chemoradiation with cetuximab and cisplatin for inoperable squamous cell carcinoma of the head and neck.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inoperable squamous cell carcinoma of the head and neck.
- Sponsor
- Institute of Oncology Ljubljana
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Squamous cell carcinoma, histologically proven.
- •\- Tumor site: oral cavity, oropharynx, hypopharynx, or larynx.
- •\- Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb), without distant metastases (M0\-stage); criteria for inoperability:
- •\-\-\> Technical unresectability,
- •\-\-\> Tumor fixation to the clavicle, base of skull or the cervical vertebrae,
- •\-\-\> Involvement of the nasopharynx or carotid artery.
- •\- Declaration of the inoperability of the patient given by a head and neck surgeon and radiation oncologist at the multidisciplinary tumor conference.
- •\- Male or female \=18 years of age.
- •\- Expected survival \> 6 months.
- •\- Presence of at least one bidimensionally measurable index lesion.
Exclusion Criteria
- •\- Metastatic disease.
- •\- Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses.
- •\- ChT or XRT ineligibility:
- •\-\-\> Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT;
- •\-\-\> Clinically evident hearing impairment;
- •\-\-\> Pre\-existing motor or sensory neurotoxicity grade \= 2 according to the CTCAE v3\.0\.
- •\- Any kind of previous therpay for SCCHN (excluding diagnostic biopsy).
- •\- Previous administration of EGFR pathway\-tergeting therapy.
- •\- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol.
- •\- Participation in another clinical trial within 30 days prior to study entry.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Radiotherapy following induction chemotherapy in locally advanced, unresectable pancreatic cance-a randomised phase 3 trial:Radiotherapy following induction chemotherapy compared with chemotherapy alone.EUCTR2009-014476-21-DEDekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath830
Active, not recruiting
Phase 1
Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-01Cervical CancerMedDRA version: 21.1Level: LLTClassification code: 10008229Term: Cervical cancer Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10008236Term: Cervical cancer stage IV Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10008235Term: Cervical cancer stage III Class: 10029104Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]CTIS2024-513576-18-00Centre Hospitalier Universitaire De Toulouse310
Suspended
Phase 3
Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-012024-513576-18-00Centre Hospitalier Universitaire De Toulouse310
Completed
Not Applicable
Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2)/IIIB non-small cell lung cancerJPRN-UMIN000006022Iseikai Hospital45
Active, not recruiting
Not Applicable
INDUCTION CHEMOTHERAPY FOLLOWED BY RADIOTHERAPY CONCOMITANT TO CETUXIMAB IN HEAD AND NECK SQUAMOUS CELL CARCINOMA: PHASE II STUDY - NDhead and neck squamous cell carcinomaMedDRA version: 9.1Level: HLTClassification code 10046311Term: Upper respiratory tract neoplasmsEUCTR2007-004099-38-ITAZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO