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Antimetabolites

Arm 3 (carboplatin/paclitaxel+high RT dose) for Esophageal Cancer (SCOPE2 Trial)

Phase 2 & 3
Waitlist Available
Led By Tom Crosby
Research Sponsored by Lisette Nixon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

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: * Standard chemotherapy and standard dose of radiotherapy * Standard chemotherapy and higher dose of radiotherapy * Alternative chemotherapy and standard dose of radiotherapy * Alternative chemotherapy and higher dose of radiotherapy 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: * Standard chemotherapy and standard dose of radiotherapy * Standard chemotherapy and higher dose of radiotherapy 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.

Eligible Conditions
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary endpoint in adenocarcinoma when switching chemotherapy
Primary endpoint in squamous cell carcinoma when switching chemotherapy
Primary endpoint phase II in squamous cell carcinoma comparing standard dose radiotherapy to high dose radiotherapy
+2 more
Secondary study objectives
Health economics
Overall survival
Progression free survival
+2 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 4 (Cisplatin+Capecitabine+high RT dose)Experimental Treatment3 Interventions
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.
Group II: Arm 3 (carboplatin/paclitaxel+high RT dose)Experimental Treatment5 Interventions
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)
Group III: Arm 2 (cisplatin/capecitabine+standard RT dose)Experimental Treatment3 Interventions
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.
Group IV: Arm 1 (carboplatin/paclitaxel+standard RT dose)Experimental Treatment5 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Cisplatin
FDA approved
Capecitabine
FDA approved
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Lisette NixonLead Sponsor
7 Previous Clinical Trials
2,990 Total Patients Enrolled
Cancer Research UKOTHER
260 Previous Clinical Trials
4,434,690 Total Patients Enrolled
Tom CrosbyPrincipal InvestigatorVelindre University NHS Trust
~65 spots leftby Dec 2025