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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52466525

Enrollment

216

Registered

2007-09-27

Start date

2007-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced squamous cell carcinoma of the head and neck Cancer Squamous cell carcinoma

Interventions

Patients with squamous cell carcinoma of the head and neck staged IVb will be randomised to either: Arm 1: cisplatin at 50 mg/m^2, administered intravenously over 60 minutes with 125 ml mannitol once

overall time of this trial is three years.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Data of interest (haematologic toxicity, presence of mucositis, skin rash, nausea/vomiting, dysphagia, odynophagia, etc) is assessed and collected at the time of each visit. The first timepoint at which the outcomes will be measured will be at 6 months after inclusion in the study. Toxicity is evaluated according to the National Cancer Institute - Common Toxicity Criteria version 3 (NCI-CTC v.3.0).	—

Measure

Time frame

Data of interest (haematologic toxicity, presence of mucositis, skin rash, nausea/vomiting, dysphagia, odynophagia, etc) is assessed and collected at the time of each visit. The first timepoint at which the outcomes will be measured will be at 6 months after inclusion in the study. Toxicity is evaluated according to the National Cancer Institute - Common Toxicity Criteria version 3 (NCI-CTC v.3.0).

—

Secondary

Measure	Time frame
Efficacy in terms of overall and progression free-survival, will be determined with clinical examination, Computed Tomography (CT)-scans, medical lab tests (metabolic profile, Complete Blood Count [CBC], blood chemistry), endoscopy and biopsy studies.	—

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026