CTRI/2007/091/000013
Completed
Phase 2
A Phase IIb RCT of Neoadjuvant chemotherapy comparing Paclitaxel, ifosfamide and Cisplatin with Paclitaxel, cisplatin and 5-FU in Patients with LocallyAdvanced Head and Neck (H&N) Cancer . - A Phase IIb RCT of Neoadjuvant chemotherapy comparing Paclitaxel, ifosfamide and Cisplatin with Paclitaxel, cisplatin and 5-FU in Patients with LocallyAdvanced Head and Neck (H&N) Cancer .
Indian Cooperative Oncology Network ICO0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indian Cooperative Oncology Network ICO
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent
- •1\) Patients must be willing and able to give written informed consent.
- •Target population
- •2\) Patients with histologically proven undifferentiated carcinoma or squamous cell
- •carcinoma (except thyroid cancer) of the oral cavity, nasopharynx, oropharynx,
- •hypopharynx, nasal cavity, paranasal sinus, or larynx
- •3\) Patients with locally advanced, Stage III\-IV (except M1\), head and neck cancer.
- •4\) Patients with at least one measurable lesion according to the RECIST criteria
- •(Section 7\.3\.2\.1\).
- •5\) Patients who have not been previously treated for head and neck cancer (surgery,
Exclusion Criteria
- •Sex and Reproductive Status Exceptions
- •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 4 weeks after the study.
- •2\) Women who are pregnant or breastfeeding
- •3\) Women with a positive pregnancy test on enrollment or prior to study drug
- •administration.
- •4\) Sexually active males unwilling to practice contraception during the study
- •Medical History and Concurrent Diseases
- •5\) Patients with a history of another malignancy (except cured basal cell carcinoma of
- •skin or cured carcinoma in\-situ of uterine cervix)
Outcomes
Primary Outcomes
Not specified
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