Condition category
Cancer
Date applied
26/12/2009
Date assigned
18/02/2010
Last edited
18/02/2010
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 Ahmad Ameri

ORCID ID

Contact details

Imam Hossein Hospital
Shahid Madani Avenue
Tehran
1617763141
Iran
Aham47@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Phase II randomised study comparing Docetaxel, Cisplatin, 5-FU (DCF) with Cisplatin, 5-FU(CF) as induction chemotherapy in head and neck cancer

Acronym

GORGANI IV

Study hypothesis

Response rate using DCF is better than CF.

Ethics approval

Approved by local medical ethics committee at the Shahid Beheshti University of Medical Sciences on the 10th of September 2009 (ref: 1001)

Study design

Phase II single centre randomised parallel group prospective clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Locally advanced head and neck cancer

Intervention

Eligible patients will be randomised to receive CF or DCF.
Patients in CF arm will receive cisplatine 75 mg/m2 on day 1 and 5Fu 750 mg/m2 on day 1 to 5 of each cycle.
Patients in DCF group will receive docetaxel 75 mg/m2 additional to above drugs on day 2 of each cycle.
Patients will receive two cycles.
After two cycles, responding patients and no-responding patients who are not candidates for surgery will be treated using chemoradiation according to the physician's opinion.
All patients will be followed every 3 to 8 week for 1 year and then every 4 to 6 month until death or recurrence.

Randomisation stratified according to PS, age (<50,>50)

Intervention type

Drug

Phase

Phase II

Drug names

Docetaxel, cisplatin, fluorouracil (5-FU) (DCF) and cisplatin, 5-FU (CF)

Primary outcome measures

Response will be evaluated at day 21 of second cycle using Response Evaluation Criteria in Solid Tumours (RECIST) criteria and computed topography (CT).

Secondary outcome measures

Toxicity will be evaluated at day 21 of each cycle and the most serious adverse effect according to WHO criteria during the cycle will be recorded.

Overall trial start date

10/07/2009

Overall trial end date

10/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological proven head and neck squamous cell carcinoma other than salivary gland tumour and sinonasal carcinoma
2. Measurable primary tumour or lymph node or both
3. T3 or T4 N0, T1-T4 N2-3
4. Age from 16 till 70 years
5. Performance status ≤2 according to ECOG classification
6. No previous chemotherapy is allowed
7. Adequate bone marrow, hepatic & renal functions
7.1. Haemoglobin ≥ 11 g/dl,
7.2. Platelets ≥ 100000 / mm3
7.3. Absolute Neutrophil Count ≥ 1500/mm3
7.4. Bilirubin = Normal Value
7.5. Transaminases = Normal Value
7.6. Creatinine ≤ 1 mg/dl
8. Absence of neuropathy
9. Absence of active co-morbid illness (uncontrolled infection, cardiopulmonary disease…)
10. Complete initial work up within 2 weeks prior to first chemotherapy infusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Any metastasis
2. Pregnant or lactating women.
3. Other serious illness or medical conditions.
4. Any chemotherapy administered before entering study
5. Any patient with early stage cancer who can be treated without mutilating surgery
6. Any contraindication for one of the drugs in chemotherapeutic regimens or radiotherapy

Recruitment start date

10/07/2009

Recruitment end date

10/12/2010

Locations

Countries of recruitment

Iran

Trial participating centre

Imam Hossein Hospital,
Tehran
1617763141
Iran

Sponsor information

Organisation

Shahid Beheshti University of Medical Sciences (Iran)

Sponsor details

Department of Radiation Oncology
Imam Hossein Hospital
Shahid Madani avenue
Tehran
1617763141
Iran

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Shahid Beheshti University of Medical Sciences (Iran)

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