Clinical trial · Interventional
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial
Prospective Randomized Phase III Trial Comparing Preoperative Chemoradiation Therapy (Cisplatin, 5-FU and Radiotherapy Followed by Surgery) to Surgery Followed by Postoperative Chemoradiation (Cisplatin, Epirubicin, 5-FU, Radiotherapy) for Esophageal Cancer
NCT00907543CI-TRIAL-00037459QUINTETTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Postoperative treatment of chemotherapy and radiation | Other | — | UNRESOLVED |
| Preoperative treatment of chemotherapy and radiation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Neoadjuvant Treatment
- description
- Preoperative chemotherapy/radiotherapy treatment
- interventionNames
- Other: Preoperative treatment of chemotherapy and radiation
- type
- EXPERIMENTAL
- label
- Adjuvant Treatment
- description
- Postoperative chemotherapy/radiotherapy treatment
- interventionNames
- Other: Postoperative treatment of chemotherapy and radiation
Primary outcomes (1)
- measure
- Quality of life as assessed by FACT-E
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20 cm from the incisors) or gastroesophageal junction are included. * No distant metastases (M0). * Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon. * Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy. * Resectable mediastinal nodes are eligible. * No prior chemotherapy for this malignancy. * No prior radiotherapy that would overlap the field(s) treated in this study. * Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer. * Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon. Exclusion Criteria: * Cancers of the cervical esophagus (\< 20 cm are excluded). * Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible. * Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible. * Patients with biopsy proven metastatic celiac nodes are ineligible.
References
Publications (1)
- DERIVEDMalthaner RA, Yu E, Sanatani M, Lewis D, Warner A, Dar AR, Yaremko BP, Bierer J, Palma DA, Fortin D, Inculet RI, Frechette E, Raphael J, Gaede S, Kuruvilla S, Younus J, Vincent MD, Rodrigues GB. The quality of life in neoadjuvant versus adjuvant therapy of esophageal cancer treatment trial (QUINTETT): Randomized parallel clinical superiority trial. Thorac Cancer. 2022 Jul;13(13):1898-1915. doi: 10.1111/1759-7714.14433. Epub 2022 May 24. PMID 35611396