Condition category
Cancer
Date applied
23/04/2008
Date assigned
26/06/2008
Last edited
14/08/2012
Prospective/Retrospective
Prospectively 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 Marc Münter

ORCID ID

Contact details

Im Neuenheimer Feld 400
Heidelberg
69120
Germany
Marc.Muenter@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

REACH

Study hypothesis

Exploratory approach: investigation on efficacy and safety of a combination of radiotherapy, Erbitux® and chemotherapy.

Ethics approval

Added 13/01/2010: Ethics Committee of the Medical Faculty, University Hospital Heidelberg, approved on the 27th April 2009.

Study design

Single treatment group, open, multi-centre design

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Erbitux®, chemotherapy (carboplatin, 5-fluorouracil [5-FU])

Primary outcome measures

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 trial start date

30/09/2008

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

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. Subject’s 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

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

Trial participating centre

Im Neuenheimer Feld 400
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

Im Neuenheimer Feld 672
Heidelberg
69120
Germany
Marc.Muenter@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://www.med.uni-heidelberg.de/index_eng.html

Funders

Funder type

Industry

Funder name

Merck KGaA (Germany)

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

1. 2012 interim results in http://www.ncbi.nlm.nih.gov/pubmed/22472064

Publication citations

  1. Interim results

    Jensen AD, Krauss J, Potthoff K, Simon C, Nikoghosyan AV, Lossner K, Debus J, Münter MW, Radiochemoimmunotherapy with intensity-modulated concomitant boost: interim analysis of the REACH trial., Radiat Oncol, 2012, 7, 57, doi: 10.1186/1748-717X-7-57.

Additional files

Editorial Notes