Study With Paclitaxel +/- Ramucirumab in Patients With Squamous-cell Carcinoma of the Esophagus After Prior Therapy (RAMOS)
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|ClinicalTrials.gov Identifier: NCT03762564|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Esophagus||Drug: Ramucirumab Drug: Paclitaxel||Phase 2|
This is a phase II, randomized, open-label multi-center study comparing treatment of paclitaxel plus ramucirumab with paclitaxel monotherapy in patients with advanced squamous-cell carcinoma (SCC) of the esophagus.
Adult patients with histologically or cytologically confirmed advanced squamous-cell carcinoma of the esophagus and refractory or intolerant to combination therapy with Fluoropyrimidine and Platinum-based drugs will be enrolled in the study.
A total number of 186 patients will be enrolled (Randomization 1:1). 93 patients will be treated with paclitaxel + ramucirumab (Arm A) and 93 with paclitaxel (Arm B).
Randomization will be stratified by time of progression during or after end of first-line therapy (≤3 months vs. >3 months).
The primary objective is to compare overall survival (OS) after 6 months in patients with squamous-cell carcinoma of the esophagus, refractory or intolerant to combination therapy with Fluoropyrimidine and Platinum-based drugs receiving paclitaxel with ramucirumab versus paclitaxel alone in the intent-to-treat population (ITT). OS is defined as the time from randomization to death from any cause.
Patients in Arm A (investigational arm) receive Paclitaxel 80 mg/m2 on day 1, 8, 15 plus Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15 every 4 weeks. Patients in Arm B (control arm) receive Paclitaxel 80 mg/m2 on day 1, 8, 15 every 4 weeks. Study treatment will be continued until progression or intolerable toxicity, but for a maximum of 1 year.
Tumor assessment will be performed according to clinical routine at screening / baseline and every 8 weeks.
After discontinuation of study medication, patients will be followed for up to 1 year. Tumor assessments per CT or MRI will be performed every 2 months for 6 months or until documentation of disease progression. Follow-up for survival will be done and documented every 2 months for the 1 year follow-up period after end of treatment.
During treatment, clinical visits (blood cell counts, detection of toxicity) will be performed prior to every treatment dose. Safety of paclitaxel +/- ramucirumab will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. Prior to the start of each cycle and at the 30-day safety follow-up visit Quality of life (QoL) will be assessed using the European Organization for Research and treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Multicenter Open Label Phase II Trial of Paclitaxel + Ramucirumab Versus Paclitaxel Alone in Patients With Squamous-cell Carcinoma of the Esophagus, Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs - The RAMOS STUDY|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||July 2023|
Experimental: Arm A (Paclitaxel + Ramucirumab)
Paclitaxel 80 mg/m2 as 1 hour intravenous infusion on day 1, 8, 15 plus Ramucirumab 8 mg/kg as 1 hour intravenous infusion on day 1 and 15 qd 28
Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15
Other Name: Cyramza
Paclitaxel 80 mg/m2 on day 1, 8, 15
Active Comparator: Arm B (control arm)
Paclitaxel 80 mg/m2 as 1 hour intravenous infusion on day 1, 8, 15 qd 28
Paclitaxel 80 mg/m2 on day 1, 8, 15
- Overall survival (OS) at 6 months [ Time Frame: 6 months ]OS rate at 6 months, defined as patients who are alive after at 6 months
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]PFS, defined as the time from randomization to the first occurrence of progression, as determined by the investigator using CT criteria, or death from any cause
- Overall survival [ Time Frame: Up to 2 years ]Overall survival according to Kaplan-Meier
- Objective response rate [ Time Frame: Up to 2 years ]Objective response rate defined as the proportion of patients with complete or partial remission according to RECIST 1.1
- Tumor control rate [ Time Frame: Up to 2 years ]Tumor control rate defined as the proportion of patients with complete or partial remission or stable disease according to RECIST 1.1
- Quality of life (QoL) [ Time Frame: Up to 1 year and 30 days ]Quality of life (QoL) as measured by EORTC-QLQ-C30 at d1 of each cycle, on EOT (end of treatment) and 30 days after EOT.
- Incidence and severity of adverse events [ Time Frame: Up to 1 year and 30 days ]incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4 criteria as assessed at day 1, 8 and 15 of every cycle during treatment for a maximum of 12 months and until 30 days after the last dose of study drug
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762564
|Contact: Sylvie Lorenzen, Prof. Dr.||+firstname.lastname@example.org|
|Contact: Claudia Pauligk, Dr.||+email@example.com|
|Institute for Clinical Cancer Research Krankenhaus Nordwest||Recruiting|
|Frankfurt, Germany, 60488|
|Contact: Salah-Eddin Al-Batran, Prof +496976014420|
|Contact: Claudia Pauligk +496976013906|
|Technische Universität München Klinikum rechts der Isar||Recruiting|
|Muenchen, Germany, 81675|
|Contact: Sylvie Lorenzen, Prof. Dr.|
|Study Chair:||Salah-Eddin Al-Batran, Prof. Dr.||Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest|