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

ISRCTN	ISRCTN52466525
DOI	https://doi.org/10.1186/ISRCTN52466525
Secondary identifying numbers	007/022/OMI

Submission date: 06/08/2007
Registration date: 27/09/2007
Last edited: 27/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jose Luis Aguilar Ponce
Scientific

St. Fernando Avenue No. 22
Sec. XVI
Mexico City
14080
Mexico

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Cisplatin concurrent with radiation therapy has been used in stage IV head and neck cancer. One previous study has reported that the combination of low-doses of gemcitabine with radiotherapy has a similar response in terms of overall survival and progression-free survival to that of cisplatin concurrent with radiation in patients with III, IVa, IVb stage disease. Based on these facts we decided to perform a randomised phase III trial to compare cisplatin concurrent with radiation versus low-dose gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck. The hypothesis being a similar response in both conditions, but better control of adverse effects with low-dose gemcitabine/radiotherapy.
Ethics approval(s)	Ethics approval received from the National Cancer Institute of Mexico Ethics and Scientific Committee (Comite de Etica y Científico del Instituto Nacional de Cancerologia) on the 5th March 2007 (ref: CB/341/06).
Health condition(s) or problem(s) studied	Advanced squamous cell carcinoma of the head and neck
Intervention	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 weekly, 3 hours before radiation. The total dose of radiation will be administered to the macroscopic tumour and to potential sites of microscopic spread was 70 Gy, over 7 weeks. Arm 2: gemcitabine at 100 mg/dl, administered intravenously over 30 minutes once weekly, 3 hours before radiation. The total dose of radiation will be administered to the macroscopic tumour and to potential sites of microscopic spread was 70 Gy, over 7 weeks. The maximal dose to the spinal cord was restricted to 45 and 54 Gy to the brain stem and optic nerves, respectively. Total treatment time is seven weeks; overall time of this trial is three years.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Gemcitabine, cisplatin, mannitol
Primary outcome measure	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 outcome measures	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.
Overall study start date	01/06/2007
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	216
Key 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
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Mexico

Study participating centre

St. Fernando Avenue No. 22

Mexico City
14080
Mexico

Sponsor information

National Cancer Institute of Mexico (Instituto Nacional de Cancerologia [INCAN]) (Mexico)
Research organisation

c/o Dr Jose Luis Aguilar Ponce
St. Fernando Avenue No. 22
Sec. XVI
Mexico, D.F.
Mexico City
14080
Mexico

"ROR"	https://ror.org/04z3afh10

Funders

Funder type

Research organisation

National Cancer Institute of Mexico (Instituto Nacional de Cancerologia [INCAN]) (Mexico)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan