Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
3 other identifiers
interventional
31
1 country
2
Brief Summary
Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 head-and-neck-cancer
Started Jul 2000
2 active sites
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 14, 2000
CompletedFirst Submitted
Initial submission to the registry
August 3, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2004
CompletedJune 16, 2017
June 1, 2017
3 years
August 3, 2000
June 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MTD of Taxotere
8 Weeks
Dose Limiting Toxicity
8 Weeks
Secondary Outcomes (2)
Overall Response Rate
4-12 weeks post chemo/radiation therapy
Tumor Resistance Predictors
Up to 1 year post chemo/radiation therapy
Study Arms (1)
Taxotere
EXPERIMENTAL* Taxotere: (1 hour infusion once a week for four weeks) * Radiation Therapy (5 days/week for 6-7 weeks) * Surgery (if required) 14 -12 weeks after radiotherapy * Follow-up
Interventions
Eligibility Criteria
You may qualify if:
- Pathology:
- \-- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.).
- Stage:
- \-- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required.
- Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan.
- Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy.
- Other Malignancies:
- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry.
- Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
- Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
- Other Prior Therapy:
- Patients treated with induction therapy
- Hormonally treated patients are eligible.
- Performance: Patients must meet the following performance criteria:
- Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required.
- +14 more criteria
You may not qualify if:
- Pathology:
- \-- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥ 2 years prior to study entry.
- Other Malignancies:
- Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
- Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
- Other Prior Therapy:
- Patients who were previously treated with radiotherapy for SCCHN are not eligible.
- Patients treated with any form of prior chemotherapy, other than induction therapy within the last 5 years are not eligible
- Performance:
- Nutritional Status: Patients requiring intravenous alimentation as primary source of calories are excluded from this study.
- Patients with persistent diarrhea are ineligible.
- Organ Function:
- \-- Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.
- \-- Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina.
- Follow-up:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy B. Tishler, MD, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2000
First Posted
January 27, 2003
Study Start
July 14, 2000
Primary Completion
July 17, 2003
Study Completion
July 3, 2004
Last Updated
June 16, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share