Phase III trial of gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck

Completed

• Conditions: Advanced squamous cell carcinoma of the head and neck; Cancer; Squamous cell carcinoma

• Registration Number: ISRCTN52466525
• Lead Sponsor: ational Cancer Institute of Mexico (Instituto Nacional de Cancerologia [INCAN]) (Mexico)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 216

Inclusion Criteria

1. International Union Against Cancer (UICC) classification stage IVb
2. Histologically proven and measurable squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
3. Previously untreated
4. Unresectable disease (when surgical resection was considered technically not feasible or surgical resection with clear margins was estimated to produce significant organ and/or function loss) or refused surgery
5. Aged 18 to 70 years
6. Squamous cell carcinoma of the head and neck without distant metastases
7. Karnofsky performance status score greater than or equal to 70%
8. Normal renal, hepatic and haematological function
9. Negative pregnancy
10. Informed consent

Exclusion Criteria

1. Surgery and chemotherapy previously
2. Previous malignancy except non-melanoma skin cancer and cervical carcinoma in situ
3. Any clinical manifestation of distant metastases
4. Therapy concurrent 30 days previous with other experimental anti-neoplastic treatment
5. Systemic and/or uncontrolled disease that precludes the use of chemotherapy
6. Hypersensibility to gemcitabine or cisplatin

Study & Design

• Study Type: Interventional
• Study Design: Not specified