NCT00021125

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for phase_3 head-and-neck-cancer

Timeline
Completed

Started Jul 2000

Typical duration for phase_3 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 26, 2013

Status Verified

December 1, 2002

First QC Date

July 11, 2001

Last Update Submit

June 25, 2013

Conditions

Head and Neck CancerNon-melanomatous Skin Cancer

Keywords

squamous cell carcinoma of the skinstage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavitysalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

  • Time to local recurrence

Secondary Outcomes (3)

  • Length of survival

  • Morbidity and toxicity

  • Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer

Interventions

adjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following: * Oral cavity * Oropharynx * Hypopharynx * Larynx * Nasal sinuses * Skin * Undergone curative surgery within the past 70 days * All macroscopic disease removed * At high or intermediate risk of recurrence * No low risk of recurrence * No evidence of distant metastases * Considered treatable by radiotherapy PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other prior or concurrent malignancy that would preclude study participation * No other uncontrolled medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

Chemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • M. I. Saunders, MD

    Mount Vernon Cancer Centre at Mount Vernon Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

July 1, 2000

Study Completion

June 1, 2007

Last Updated

June 26, 2013

Record last verified: 2002-12

Locations

GB(1)