Radiotherapy (intensity-modulated radiation therapy [IMRT]), Erbitux® And CHemotherapy for unresectable carcinomas of head and neck
| ISRCTN | ISRCTN87356938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87356938 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/04/2008
- Registration date
- 26/06/2008
- Last edited
- 02/11/2022
- 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
Not provided at time of registration
Contact information
Dr Marc Münter
Scientific
Scientific
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
| Marc.Muenter@med.uni-heidelberg.de |
Study information
| Study design | Single treatment group, open, multi-centre design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Radiotherapy (intensity-modulated radiation therapy [IMRT]), Erbitux® And CHemotherapy for unresectable carcinomas of head and neck |
| Study acronym | REACH |
| Study hypothesis | Exploratory approach: investigation on efficacy and safety of a combination of radiotherapy, Erbitux® and chemotherapy. |
| Ethics approval(s) | Added 13/01/2010: Ethics Committee of the Medical Faculty, University Hospital Heidelberg, approved on the 27th April 2009. |
| Condition | Unresectable carcinomas of head and neck |
| Intervention | This is a single-arm trial. Treatment is a combination of: 1. Intensity-modulated radiotherapy, 1.8 Gy/day. Schedule of administration: study days 8 - 12, 15 - 19, 22 - 26, 29 - 33, 36 - 40 and 43 - 45 from study day 29 onwards; an additional concomitant boost will be given (1.5 Gy/day 29 - 33, 36 - 40 and 43 - 45) 2. Chemotherapy - carboplatin 70 mg/m^2 of body surface and 5-fluorouracil (5-FU) 600 mg/m^2 on study days 8 - 12 and 36 - 40 3. Cetuximab (Erbitux®): 400 mg/m^2 of body surface on study day 1 and 250 mg/m^2 on study days 8, 15, 22, 29, 36, 43 Total duration of treatment 45 days; total duration of follow-up: up to 60 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Erbitux®, chemotherapy (carboplatin, 5-fluorouracil [5-FU]) |
| Primary outcome measure | Local-regional control. All outcome measures will be determined at the same time during the study (follow-up visits): 1st follow-up: six weeks after completion of the treatment, i.e. after day 45 2nd follow-up: three months after 1st follow-up 3rd follow-up: three months after 2nd follow-up 4th and further follow-ups every six months for up to five years after trial beginning |
| Secondary outcome measures | 1. Disease-free survival 2. Progression-free survival 3. Overall survival 4. Acute radiation effects 5. Late radiation effects 6. Adverse events 7. Proteomics and genomics All outcome measures will be determined at the same time during the study (follow-up visits): 1st follow-up: six weeks after completion of the treatment, i.e. after day 45 2nd follow-up: three months after 1st follow-up 3rd follow-up: three months after 2nd follow-up 4th and further follow-ups every six months for up to five years after trial beginning |
| Overall study start date | 30/09/2008 |
| Overall study end date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Signed written informed consent 2. Aged 18 to 70 years, either sex 3. Life expectancy of at least six months 4. Ability of subject to understand character and individual consequences of clinical trial 5. Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of the oro-, hypopharynx or larynx (T2-4, NX,M0) 6. Oral cavity or oro- or hypopharynx as the primary tumour site 7. At least one uni-measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria 8. Karnofsky Performances Status greater than 70% 9. Adequate bone marrow function: 9.1. Neutrophils greater than 1.5 x 10^9/L 9.2. Platelets greater than 100 x 10^9/L 9.3. Haemoglobin greater than 10.0 g/dL 10. Adequate liver function: 10.1. Bilirubin less than 2.0 g/dL 10.2. Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase (AP), gamma-glutamyl transferase (gGT) less than 3 x upper limit of normal (ULN) 11. Adequate renal function: serum creatinine less than 1.5 mg/dL 12. Negative serum/urine beta-human chorionic gonadotropin (B-HCG) test in women of childbearing potential 13. Women of childbearing potential: willingness to use effective contraceptive method, defined as the concomitant use of either an intrauterine pessary (IUP) or contraceptive pill and in both cases, condoms for the treatment duration and two months thereafter. Women of non-childbearing potiential are those who are post-menopausal for at least one year or sterilised 14. Men of procreative potential: willingness for effective prevention of procreation, defined as a use of condoms and a use of an intrauterine pessary (IUP) or a contraceptive pill by his partner for the treatment duration and two months thereafter 15. Subjects consent to collect blood samples for proteomics and genomics analysis. If a patient does not consent, no blood samples for proteomics and genomics will be taken. Nonetheless, he/she may be enrolled in the study. |
| Participant exclusion criteria | 1. Previous chemotherapy, radiotherapy or surgery for carcinoma of the head and neck 2. Nasopharyngeal carcinoma 3. Prior exposure to epidermal growth factor receptor (EGFR) pathway targeting therapy 4. Other serious illness or medical conditions: 4.1. Unstable cardiac disease despite treatment 4.2. Congestive heart failure New York Heart Association (NYHA) grade 3 and 4 4.3. Significant neurologic or psychiatric disorders including dementia or seizures 4.4. Active disseminated intravascular coagulation 4.5. Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study 4.6. Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher 4.7. Ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumour mass 5. Participation in other interventional trials within the last 30 days 6. Surgery within the last 30 days 7. Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment 8. Women: pregnant or breast-feeding 9. Known drug abuse 10. Other previous malignancy within five years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix 11. Legal incapacity or limited legal capacity 12. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent |
| Recruitment start date | 30/09/2008 |
| Recruitment end date | 31/12/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany)
University/education
University/education
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Marc.Muenter@med.uni-heidelberg.de | |
| Website | http://www.med.uni-heidelberg.de/index_eng.html |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
Industry
Merck KGaA
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Merck, Merck Group
- Location
- Germany
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 02/04/2012 | Yes | No | |
| Protocol article | 26/11/2010 | 02/11/2022 | Yes | No |
Editorial Notes
02/11/2022: Publication reference added.
