Comparative study of two different induction chemotherapy regimens in head and neck cancer
| ISRCTN | ISRCTN08658578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08658578 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/12/2009
- Registration date
- 18/02/2010
- Last edited
- 18/02/2010
- 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 Ahmad Ameri
Scientific
Scientific
Imam Hossein Hospital
Shahid Madani Avenue
Tehran
1617763141
Iran
| Aham47@yahoo.com |
Study information
| Study design | Phase II single centre randomised parallel group prospective clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | GORGANI IV |
| Study objectives | Response rate using DCF is better than CF. |
| Ethics approval(s) | Approved by local medical ethics committee at the Shahid Beheshti University of Medical Sciences on the 10th of September 2009 (ref: 1001) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Docetaxel, cisplatin, fluorouracil (5-FU) (DCF) and cisplatin, 5-FU (CF) |
| Primary outcome measure | 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 study start date | 10/07/2009 |
| Completion date | 10/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/07/2009 |
| Date of final enrolment | 10/12/2010 |
Locations
Countries of recruitment
- Iran
Study participating centre
Imam Hossein Hospital,
Tehran
1617763141
Iran
1617763141
Iran
Sponsor information
Shahid Beheshti University of Medical Sciences (Iran)
University/education
University/education
Department of Radiation Oncology
Imam Hossein Hospital
Shahid Madani avenue
Tehran
1617763141
Iran
"ROR" |
https://ror.org/034m2b326 |
|---|
Funders
Funder type
University/education
Shahid Beheshti University of Medical Sciences (Iran)
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 |
