Condition category
Cancer
Date applied
06/08/2007
Date assigned
27/09/2007
Last edited
27/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Luis Aguilar Ponce

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

007/022/OMI

Study information

Scientific title

Acronym

Study hypothesis

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

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Gemcitabine, cisplatin, mannitol

Primary outcome measures

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 trial start date

01/06/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

216

Participant 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

Recruitment start date

01/06/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Mexico

Trial participating centre

St. Fernando Avenue No. 22
Mexico City
14080
Mexico

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes