Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

Carcinoma, Squamous Cell Clinical Trial

— NeoRes  

Official title:

Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362127
• Other study ID #: EU-nr 2006-001785-16
• Secondary ID: 2006-001785-16
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Est. completion date: June 25, 2018

Study information

• Verified date: February 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 25, 2018
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagus and Gastric Cardia
• Carcinoma, Squamous Cell
• Esophageal Neoplasms

Intervention

Drug:
• Chemotherapy
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.

Radiation:
• Radiochemotherapy
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.

Locations

Country	Name	City	State
Sweden	Upper Digestive Diseases. Department of surgery, Karolinska University Hospital	Stockholm

Sponsors (9)

Lead Sponsor	Collaborator
Karolinska University Hospital	Haukeland University Hospital, Malarhospital Eskilstuna, Oslo University Hospital, Region Örebro County, Sahlgrenska University Hospital, Sweden, St. Olavs Hospital, Ullevaal University Hospital, University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Klevebro F, Alexandersson von Döbeln 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 — View Citation

Klevebro F, Johnsen G, Johnson E, Viste A, Myrnäs 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 — View Citation

Sunde 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 — View Citation

Sunde 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 — View Citation

von Döbeln 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of Respective Neoadjuvant Therapies.	Safety profile of carrying out radical surgery after respective neoadjuvant therapy.	Five years follow up
Secondary	HRQOL and Swallowing Function	The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease specific questionnaires (QLQ-OES24/OG25). All items included in the questionnaires are analysed and also separate analysis of dysphagia questionnaires for oesophageal cancer were used, both clinically and psychometrically validated. All questions have four response alternatives (1, not at all; 2:a little, 3: quite a bit, 4: very much), except global scales which comprise seven response alternatives from poor to excellent. Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 according to the EORTC scoring manual. A higher score indicates either more symotoms or better function, depending on the question.	Entry study up to Five years follow up