PReoperative Chemoradiation (Paclitaxel-carboplatin or FOLFOX) for Resectable Esophageal and Junc… (NCT02359968) | Clinical Trial Compass
CompletedPhase 2
PReoperative Chemoradiation (Paclitaxel-carboplatin or FOLFOX) for Resectable Esophageal and Junctional Cancer
France106 participantsStarted 2015-02-26
Plain-language summary
Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy treatment is the FOLFOX. It is a combination of three drugs administered intravenously: fluorouracil, oxaliplatin and folinic acid. This is the standard treatment.
Another protocol of chemotherapy is widely used by certain European and American teams, due to promising results : a combination of two drugs administered intravenously: Paclitaxel and Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one treatment over the other.
The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Resectable and operable esophageal cancer located under the carena (beyond 25 cm from the incisors) or junctional cancer (Siewert I or II)
* Invasive adenocarcinoma or squamous cell type (to stick to the population included in the CROSS trial)
* Patient who present with:
* stage IIA (T3N0M0)
* stage IIB (T1 N1 M0 or T2 N1 M0),
* stage III (T3 N1 M0 or T4 N0 N1 M0) tumors
* ECOG performance status 0, 1 or 2
* Patient eligible for preoperative chemoradiation with either fluorouracil- oxaliplatin-folinic acid, or Paclitaxel-carboplatin
* Age ≥ 18
* Peripheral neuropathy ≤ NCI-CTC grade 1
* Adequate bone marrow reserve, normal renal and liver functions:
* Neutrophil count ≥ 1500/mm3
* Platelet count ≥ 100 000/mm3
* Hemoglobin ≥ 10 g/dl (after transfusion, if necessary)
* Creatinin \< 15mg/L
* Clearance of creatinin (Cockcroft formulae) ≥ 60 ml/mn
* Prothrombin time ≥ 60%
* ASAT-ALAT ≤2.5 x ULN
* Total bilirubin \< 1.5 x ULN
* Albumin greater the lower limit of normal
* Start of treatment within 28 days after randomization
* Negative pregnancy test (serum beta-HCG) performed within 1 week prior to start of study treatment in females with reproductive potential
* Patient covered by government health insurance
* Patient who provide a signed written informed consent form
Exclusion Criteria:
* Patient who present with stage I or stage IIA (including T2 N0 M0) or stage IV
* Patient who present with common contraindications for surgery …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short-term benefit of 2 preoperative regimen: complete resection rate AND severe (grade ≥ 3) postoperative morbidity/mortality according to the Clavien-Dindo classification