Phase 2
N=181
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
Carcinoma, Squamous Cell · Adenocarcinoma of the Esophagus and Gastric Cardia
Bottom Line
View on ClinicalTrials.gov: NCT01362127 ↗Enrolled (actual)
181
Serious AEs
54.1%
Results posted
Feb 2020
Primary outcome: Primary: Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. — 22; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Chemotherapy (Drug); Radiochemotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska University Hospital
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia. |
22; 7 | — |
| SECONDARY Safety of Respective Neoadjuvant Therapies. |
79; 81 | — |
| SECONDARY HRQOL and Swallowing Function |
67; 69; 27; 31 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01362127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.