Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia (NeoRes)
This study is currently recruiting participants.
Verified February 2012 by Karolinska University Hospital
Sponsor:
Karolinska University Hospital
Collaborators:
University Hospital, Umeå
University Hospital Orebro
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Haukeland University Hospital
Oslo University Hospital
St. Olavs Hospital
Malarhospital Eskilstuna
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01362127
First received: May 26, 2011
Last updated: February 6, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Squamous Cell Adenocarcinoma of the Esophagus and Gastric Cardia |
Drug: Chemotherapy Radiation: Radiochemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy |
Resource links provided by NLM:
Further study details as provided by Karolinska University Hospital:
Primary Outcome Measures:
- To evaluate whether radiochemotherapy gives higher complete histological response (pCR) after resection than chemotherapy alone in patients with resectable carcinoma of the esophagus and cardia. [ Time Frame: Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the safety of respective neoadjuvant therapies. [ Time Frame: Three years follow up ] [ Designated as safety issue: Yes ]
To assess the safety profile of carrying out radical surgery after respective neoadjuvant therapy.
To study the overall and disease free survival in respective groups. To evaluate if pretreatment tumor characteristics predict the pCR and oncomplete pCR rates.
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Radiochemotherapy
Radiochemotherapy + Surgery
|
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.
Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
|
|
Active Comparator: Chemotherapy
Chemotherapy + surgery
|
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.
Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
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.
Other Name: Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362127
Locations
| Sweden | |
| Gastrocentrum. Department of surgery, Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 14186 | |
| Contact: Lars Lundell, Professor +46858586721 lars.lundell@karolinska.se | |
| Contact: Jon Tsai, Ass. Prof. +46858586721 jon.tsai@ki.se | |
| Principal Investigator: Lars Lundell, Professor | |
Sponsors and Collaborators
Karolinska University Hospital
University Hospital, Umeå
University Hospital Orebro
Sahlgrenska University Hospital, Sweden
Ullevaal University Hospital
Haukeland University Hospital
Oslo University Hospital
St. Olavs Hospital
Malarhospital Eskilstuna
Investigators
| Principal Investigator: | Lars Lundell, Professor | Karolinska University Hospital, Gastrocentrum |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lars Lundell, Professor, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT01362127 History of Changes |
| Other Study ID Numbers: | EU-nr 2006-001785-16, 2006-001785-16 |
| Study First Received: | May 26, 2011 |
| Last Updated: | February 6, 2012 |
| Health Authority: | Sweden: Medical Products Agency Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska University Hospital:
|
Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery. |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Oxaliplatin Cisplatin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013