Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01843829
Other study ID # 2012/VCC/0009
Secondary ID
Status Recruiting
Phase Phase 2
First received March 7, 2013
Last updated March 21, 2014
Start date October 2013
Est. completion date May 2016

Study information

Verified date March 2014
Source Velindre NHS Trust
Contact Lisette Nixon
Phone 02920687458
Email nixonls@cardiff.ac.uk
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less than a quarter have resectable disease at diagnosis. There is a general lack of consistency in the standard of care for patients across UK hospitals. Patients are either treated with a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by removal of the tumour by surgery, as part of their standard of care. Recent research supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and preventing the disease from spreading than taking chemotherapy alone. However, there is no definitive way of identifying which treatment is best without a clinical trial.

Evidence suggests that the effect of the chemoradiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemoradiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemoradiotherapy regimens (carboplatin and paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in previous studies. Patients will then have their tumour removed. The best chemoradiotherapy regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be compared with chemotherapy alone.

The efficacy of the regimens will be measured by counting the number of patients who i) remain free from cancer, ii)have local or distant spread of their cancer, iii) are successfully recruited and iv) experience toxicities. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 85
Est. completion date May 2016
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed operable oesophageal cancer (adenocarcinoma)

- Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13 using TNM7 staging)

- Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET

- WHO performance status 01

- Adequate haematological, renal, respiratory, cardiac and hepatic function

- The patient has provided written informed consent.

Exclusion Criteria:

- Histologically confirmed operable oesophageal cancer (squamous cell carcinoma)

- Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG.

- Patients with any previous treatment for oesophageal carcinoma.

- Siewert type 3 oesophagogastric tumours.

- T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura.

- Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation:

1. Evidence of metastases in liver, lung, bone or other distant metastases.

2. Abdominal para aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS.

3. Invasion of tracheo-bronchial tree, aorta, pericardium or lung.

- Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded).

- Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies.

- Specific contraindications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy.

- Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Oxaliplatin

Capecitabine

Carboplatin

Paclitaxel

Radiation:
Radiotherapy

Procedure:
Surgery
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.

Locations

Country Name City State
United Kingdom Bristol Oncology and Haematology Centre Bristol
United Kingdom Valindre NHS Cardiff
United Kingdom University Hospitals Coventry and Warwickshire Coventry
United Kingdom Royal Derby Hospital Derby
United Kingdom St James's Hospital Leeds
United Kingdom Leicester Royal Infirmary Leicester
United Kingdom St Mary's Hopsital London
United Kingdom The Christie Manchester
United Kingdom Churchill Hospital Oxford
United Kingdom Weston Park Hospital Sheffield
United Kingdom Southampton General Hospital Southampton
United Kingdom The Great Western Hospital Swindon

Sponsors (2)

Lead Sponsor Collaborator
Lisette Nixon Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy The efficacy of the trial treatment will be assessed by conducting analysis on the resected tumour specimen of participants undergoing surgery. This will be achieved by looking at the pathological complete response rate (pCR). 24 months No
Secondary Feasibility of recruiting 62 patients within 18 months Feasibility of recruiting to a pre-operative chemoradiotherapy trial in the UK will be determined by recruitment within 18 months. 18 months No
Secondary Safety The trial safety will be assessed by looking at the toxicity. Toxicities during treatment and at 6 and 12 months post-surgery will be recorded using the CTCAE version 4. SAEs will be collected in real time. The morbidity/mortality rate post surgery will also be assessed. 3 years Yes
Secondary Efficacy The efficacy will be measured as a secondary end point by assessing the median, 3 and 5 year overall survival. 5 years No
Secondary Efficacy The CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour, will be assessed. 24 months No
See also
  Status Clinical Trial Phase
Recruiting NCT05685862 - Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit
Recruiting NCT01795768 - Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours Phase 2
Completed NCT05266300 - Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Recruiting NCT03978377 - Cardiopulmonary Toxicity of Thoracic Radiotherapy
Active, not recruiting NCT03653052 - Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab Phase 2
Recruiting NCT05489250 - The PLATON Network
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Terminated NCT01795976 - NY-ESO-1 T Cells in OG Cancer Phase 2
Completed NCT01915693 - ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study Phase 3
Completed NCT02382237 - Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition N/A
Recruiting NCT04517448 - Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
Recruiting NCT04232735 - Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) N/A
Recruiting NCT05642819 - REVOLUTION Surgery (REVOLUTION Surgery)
Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Recruiting NCT02741856 - Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation Phase 2/Phase 3
Not yet recruiting NCT05600608 - Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome N/A
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Recruiting NCT05057013 - HMBD-001 in Advanced HER3 Positive Solid Tumours Phase 1/Phase 2
Not yet recruiting NCT06046846 - Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer N/A
Recruiting NCT04564482 - PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer N/A