A Phase 2/3 interventional study of Carboplatin and Paclitaxel in Oesophageal Cancer, sponsored by Lisette Nixon. Status unknown at 26 sites in United Kingdom. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by Lisette Nixon · Phase 2/3, Interventional, and Treatment
Research has shown that increasing the dose of radiotherapy improves outcomes in patients with lung and head and neck cancers. This study aims to see whether this is also the case for patients with tumour of the oesophagus. This trial will compare the effects of the standard dose of radiotherapy to a higher dose whilst closely monitoring the side effects.
A comparison will also be made regarding the effects of the standard drugs used in chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and paclitaxel) in patients that do not show a response to chemotherapy with standard drugs early on in treatment.
All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.
How the study will be conducted:
Prior to the commencement of treatment each patient will have a special scan called a PET scan. Patients will receive a second PET scan two weeks after the start of standard chemotherapy. The changes between the two scans will then be used to allocate treatment into the different arms of the study. All study subjects will be randomised to receive either the standard radiotherapy dose or the high radiotherapy dose. The participants that do not respond to the first cycle of standard chemotherapy will be eligible to take part in the aspect of the trial looking at an alternative chemotherapy regimen. Patients will be randomised as follows;
On the basis of the second PET scan, patients who are not responding to standard chemotherapy will be allocated by a computer to one of the four groups detailed below:
Patients who are responding to standard chemotherapy (or where the response is unknown or those who were not eligible for PET scan portion of the study) will be allocated by a computer to one of two groups detailed below:
The arms within each of the groups above (responders and non-responders) will be equal in size and patients will be allocated randomly by a computer.
This study will also compare the way that this treatment affects the two different cell types found in oesophageal tumours.
The effects of the different treatment, together with the costs of the different treatment and the effects on quality of life will be analysed to see which is more effective for each of the different groups.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 584 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Lisette Nixon is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main inclusion criteria:
Patients who have provided written informed consent prior to enrolment.
Additional inclusion criteria for patient eligibility for PET randomisation (cisplatin/capecitabine vs carboplatin/paclitaxel) as assessed at local centre:
Patients that are eligible for the trial but are ineligible for PET randomisation will be randomised to receive 50/60Gy radiotherapy plus cisplatin and capecitabine.
* Patients where the EUS scope is unable to pass are eligible.
Main exclusion criteria:
Cycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: carboplatin AUC 5 on D1 and paclitaxel 175mg/m2 on D1 Week 7-11: Weekly carboplatin AUC 2 and paclitaxel 50mg/m2 concomitant with radiotherapy (50Gy/25 fractions)
Drug: Carboplatin · Drug: Paclitaxel · Drug: Cisplatin · Drug: Capecitabine · Radiation: Radiotherapy
Cycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 3: Week 7-9: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 4: Week 10-11: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-14 Cycles 3 and 4 are given concomitantly with radiotherapy (50Gy/25 fractions). Capecitabine stops on last day of RT.
Drug: Cisplatin · Drug: Capecitabine · Radiation: Radiotherapy
Cycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: carboplatin AUC 5 on D1 and paclitaxel 175mg/m2 on D1 Week 7-11: Weekly carboplatin AUC 2 and paclitaxel 50mg/m2 concomitant with radiotherapy (60Gy/25 fractions)
Drug: Carboplatin · Drug: Paclitaxel · Drug: Cisplatin · Drug: Capecitabine · Radiation: Radiotherapy
Cycle 1: Week 1-3: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 2: Week 4-6: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 3: Week 7-9: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-21 Cycle 4: Week 10-11: cisplatin 60mg/m2 on D1 and capecitabine 625mg/m2 bd D1-14 Cycles 3 and 4 are given concomitantly with radiotherapy (60Gy/25 fractions). Capecitabine stops on last day of RT.
Drug: Cisplatin · Drug: Capecitabine · Radiation: Radiotherapy
For more information please see the arm descriptions section.
For more information please see the arm descriptions section.
For more information please see the arm descriptions section.
For more information please see the arm descriptions section.
For more information please see the arm descriptions section.
Primary endpoint phase II in squamous cell carcinoma comparing standard dose radiotherapy to high dose radiotherapy
24 week treatment failure free survival (TFFS).
Time frame: 24 weeks
Primary endpoint phase III in squamous cell carcinoma: Overall survival (OS) comparing standard dose radiotherapy to high dose radiotherapy
Overall survival (OS)
Time frame: 24 weeks
Primary endpoint in squamous cell carcinoma when switching chemotherapy
24 week treatment failure free survival (TFFS).
Time frame: 24 weeks
Primary endpoint phase in adenocarcinoma phase II comparing standard dose radiotherapy to high dose radiotherapy
24 week treatment failure free survival (TFFS).
Time frame: 24 weeks
Primary endpoint in adenocarcinoma when switching chemotherapy
24 week treatment failure free survival (TFFS).
Time frame: 24 weeks
Overall survival
Overall survival assessed at each visit. Additionally patients will be flagged with the HSCIC to reduce loss to follow up.
Time frame: 5 years follow up
Progression free survival
Progression free survival (PFS), additionally patients will be flagged with the HSCIC to reduce loss to follow up.
Time frame: 5 years
Quality of Life
Quality of Life (QoL): EORTC QLQ-C30 and EORTC QLQ-OES18 questionnaires
Time frame: Baseline, week 7, end of treatment, 6, 12 and 24 months
Toxicity
CTCAE v4.03 at baseline, after each treatment cycle, and follow up visits. Patients in the dose escalation arm will have additional assessment and 6 and 9 weeks post RT to monitor toxicities.
Time frame: After each treatment cycle and at follow up visits
Health economics
Health economic data will be collected using health resource utilisation log plus data on health resource usage
Time frame: Baseline, end of treatment, 6, 12 and 24 months
Plan to share: Undecided
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lisette Nixon