Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
NeoRes
Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy
2 other identifiers
interventional
181
1 country
1
Brief Summary
The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2018
CompletedResults Posted
Study results publicly available
February 26, 2020
CompletedFebruary 26, 2020
February 1, 2020
6.7 years
May 26, 2011
April 16, 2019
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
Chireac tumour regression grade
Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.
Secondary Outcomes (2)
Safety of Respective Neoadjuvant Therapies.
Five years follow up
HRQOL and Swallowing Function
Entry study up to Five years follow up
Study Arms (2)
Radiochemotherapy
ACTIVE COMPARATORArm I: Radiochemotherapy + Surgery
Chemotherapy
ACTIVE COMPARATORArm II: Chemotherapy + surgery
Interventions
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
Eligibility Criteria
You may qualify if:
- Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II)
- Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation
- Adequate haemotological function, defined as having WBC \> 3 x 10(9)/litre and platelets \> 100 x 10 (9)/litre.
- Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate \> 60 ml/min.
- Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a
You may not qualify if:
- Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used
- Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy.
- Concomitant malignancy (\< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment.
- Patients being unable tom comply with the protocol
- Tumor stage T1 N0, T4 NX or TXNXM1b
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- University Hospital, Umeåcollaborator
- Region Örebro Countycollaborator
- Sahlgrenska University Hospitalcollaborator
- Ullevaal University Hospitalcollaborator
- Haukeland University Hospitalcollaborator
- Oslo University Hospitalcollaborator
- St. Olavs Hospitalcollaborator
- Malarhospital Eskilstunacollaborator
Study Sites (1)
Upper Digestive Diseases. Department of surgery, Karolinska University Hospital
Stockholm, 14186, Sweden
Related Publications (7)
Klevebro F, Alexandersson von Dobeln G, Wang N, Johnsen G, Jacobsen AB, Friesland S, Hatlevoll I, Glenjen NI, Lind P, Tsai JA, Lundell L, Nilsson M. A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction. Ann Oncol. 2016 Apr;27(4):660-7. doi: 10.1093/annonc/mdw010. Epub 2016 Jan 17.
PMID: 26782957RESULTSunde B, Klevebro F, Johar A, Johnsen G, Jacobsen AB, Glenjen NI, Friesland S, Lindblad M, Ajengui A, Lundell L, Lagergren P, Nilsson M. Health-related quality of life in a randomized trial of neoadjuvant chemotherapy or chemoradiotherapy plus surgery in patients with oesophageal cancer (NeoRes trial). Br J Surg. 2019 Oct;106(11):1452-1463. doi: 10.1002/bjs.11246. Epub 2019 Aug 22.
PMID: 31436322RESULTvon Dobeln GA, Klevebro F, Jacobsen AB, Johannessen HO, Nielsen NH, Johnsen G, Hatlevoll I, Glenjen NI, Friesland S, Lundell L, Yu J, Nilsson M. Neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the esophagus or gastroesophageal junction: long-term results of a randomized clinical trial. Dis Esophagus. 2019 Feb 1;32(2). doi: 10.1093/dote/doy078.
PMID: 30137281RESULTKlevebro F, Johnsen G, Johnson E, Viste A, Myrnas T, Szabo E, Jacobsen AB, Friesland S, Tsai JA, Persson S, Lindblad M, Lundell L, Nilsson M. Morbidity and mortality after surgery for cancer of the oesophagus and gastro-oesophageal junction: A randomized clinical trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation. Eur J Surg Oncol. 2015 Jul;41(7):920-6. doi: 10.1016/j.ejso.2015.03.226. Epub 2015 Apr 8.
PMID: 25908010RESULTSunde B, Johnsen G, Jacobsen AB, Glenjen NI, Friesland S, Lindblad M, Rouvelas I, Wang N, Lundell L, Lagergren P, Nilsson M. Effects of neoadjuvant chemoradiotherapy vs chemotherapy alone on the relief of dysphagia in esophageal cancer patients: secondary endpoint analysis in a randomized trial. Dis Esophagus. 2019 Feb 1;32(2). doi: 10.1093/dote/doy069.
PMID: 30084992RESULTLund M, Tsai JA, Nilsson M, Winter R, Lundell L, Kalman S. Effects of neoadjuvant chemo or chemoradiotherapy for oesophageal cancer on perioperative haemodynamics: A prospective cohort study within a randomised clinical trial. Eur J Anaesthesiol. 2016 Sep;33(9):653-61. doi: 10.1097/EJA.0000000000000480.
PMID: 27254026DERIVEDLund M, Alexandersson von Dobeln G, Nilsson M, Winter R, Lundell L, Tsai JA, Kalman S. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial. Radiat Oncol. 2015 Jan 13;10:16. doi: 10.1186/s13014-014-0310-7.
PMID: 25582305DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Fredrik Klevebro
- Organization
- Karolinska Institutet
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Nilsson, Professor
Karolinska University Hospital, Gastrocentrum
- STUDY CHAIR
Lars Lundell, Professor
Karolinska University Hospital, Gastrocentrum
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass Professor
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 27, 2011
Study Start
October 1, 2006
Primary Completion
June 1, 2013
Study Completion
June 25, 2018
Last Updated
February 26, 2020
Results First Posted
February 26, 2020
Record last verified: 2020-02