Clinical trial · Interventional
Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer
Randomized Clinical Trial Comparing the Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Cancer of the Esophagus or Gastric Cardia
- 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)
This study compares outcomes with regard to the timing of resective surgery after neoadjuvant chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study hypothesis is that a longer delay improves histological response and decreases the risk of postoperative morbidity and mortality.
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 |
|---|---|---|---|
| Cancer of the Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resective surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Resective surgery after 4-6 weeks
- description
- Resective surgery 4-6 weeks after completed chemoradiotherapy (CRT)
- interventionNames
- Procedure: Resective surgery
- type
- ACTIVE_COMPARATOR
- label
- Resective surgery after 10-12 weeks
- description
- Resective surgery 10-12 weeks after completed chemoradiotherapy (CRT)
- interventionNames
- Procedure: Resective surgery
Primary outcomes (1)
- measure
- Complete histological response proportion, using the Chirieac grading system.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified adenocarcinoma or SCC of the esophagus or GEJ Siewert type I and II. * Tumors should be resectable and without distant metastasis, as assessed after completed CRT. * Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations. * Pre CRT tumor stage: T1N1-3M0, T2N0-3M0, T3N0-3,M0, T4aN0-3,M0 * Written informed consent * Completed at least 80% of the planned chemotherapy and at least 90% of the prescribed radiotherapy dose within the neoadjuvant CRT schedule according to protocol within a period of \<36 days. Exclusion Criteria: * Concomitant malignant diagnosis (excluding non-melanoma skin cancer) \<5 years since current cancer diagnosis. * Ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy. * Patients being unable to comply with the protocol for reasons of language or cognitive function. * Tumor stage T1N0, T4bNX or TXNXM1. * Carcinoma of the upper third of the esophagus (i.e. cervical and uppermost thoracic) for simplicity here defined as upper border of tumor above 22 cm from incisors at endoscopy. * Clear radiological signs of tumor progression during CRT on CT-scan after completion of CRT. PET is not used in this decision as FDG-activity often increase due to radiotherapy induced inflammation.
References
Publications (1)
- DERIVEDNilsson K, Klevebro F, Rouvelas I, Lindblad M, Szabo E, Halldestam I, Smedh U, Wallner B, Johansson J, Johnsen G, Aahlin EK, Johannessen HO, Hjortland GO, Bartella I, Schroder W, Bruns C, Nilsson M. Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer. Ann Surg. 2020 Nov;272(5):684-689. doi: 10.1097/SLA.0000000000004340. PMID 32833767