Other Clinical Trial - Phase III Trial Comparing Methotrexate & Cetuximab

Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer — ELAN-UNFIT

Head Neck Cancer Squamous Cell Recurrent Clinical Trial

Official title:
Multicentric Randomized Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer in Elderly Unfit Patients According to Geriatric Evaluation

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT01527877` - Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck	Phase 2
	Completed	`NCT01449201` - PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma	Phase 2

See also

Status

Clinical Trial

Phase

Recruiting

NCT01527877 - Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck

Phase 2

Completed

NCT01449201 - PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01884623
Study type	Interventional
Source	Gustave Roussy, Cancer Campus, Grand Paris
Contact
Status	Completed
Phase	Phase 3
Start date	November 6, 2013
Completion date	October 12, 2021

Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer — ELAN-UNFIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms