It seems logical that when the same treatment is applied before surgery, that patients will tolerate this easier. Analogous to rectal cancer it is assumed that by reducing tumor size, surgical outcome can be improved. In this preoperative approach,…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy (resectability rate, pCR rate, R0 rate) and safety
Secondary outcome
• Disease free survival and overall survival
• To investigate if PET (positron emission tomography) imaging before, during
and after chemoradiotherapy can predict pathological response
• Collect tissue and serum before chemoradiotherapy for genomic profiling and
proteomics to detect tumor recurrence risk patterns in gastric cancer
Background summary
After resection of gastric or esophageal cancer there is a high chance on a
local recurrennce, which is highly dependent on the pathological state.
Recently postoperative chemoradiotherapy showed to decrease the number of
recurrences and to improve survival. However, this treatment demonstrated to be
toxic, mainly because postoperatively a large part of the upper abdomen should
be in the radiation portals.
Study objective
It seems logical that when the same treatment is applied before surgery, that
patients will tolerate this easier. Analogous to rectal cancer it is assumed
that by reducing tumor size, surgical outcome can be improved. In this
preoperative approach, a daily combination radiotherapy and chemotherapy will
be applied that is routinely used in the neoadjuvant treatment of esophageal
cancer.
This study is a phase I-II study, which can be tested in a randomized phase III
trial later.
Study design
In this phase I-II study we will explore the operability, pCR rate and safety
of induction chemoradiotherapy consisting of 5 weeks concurrent carboplatin,
paclitaxel, and radiotherapy in patients with locally advanced gastric cancer.
Intervention
na
Study burden and risks
most of the examinations that are being performed in this protocol are part of
the regular workup of patients that undergo chemoradiation and gastric surgery
Plesmanlaan 121
1066 CX
Nederland
Plesmanlaan 121
1066 CX
Nederland
Listed location countries
Age
Inclusion criteria
• T4 tumors (extension into the esophagus is acceptable as long as the bulk (>50%) of the tumor is in the stomach), and/or N2 nodes > 7 suspected nodes on EUS or CT scan, and/or one large lymph node (mass or conglomerate), and/or > 3 suspected lymph nodes in truncus / para-aortal / spleen hilus. All lymphnodes have to be in cranial position of the renal arteries (in other words tumors that are not suitable for participation in the CRITICS (M06CRI) study)
* stage Ib-IVa (no distant metastases) gastric cancer (histologically confirmed); tumor bulk has to in the stomach but may involve the gastro-esophageal junction
• WHO <= 2
* age 18-70
* gastric cancer should be operable according to one of the coordinating surgeons
* tumornegative laparoscopy
* no prior RT abdomen and/or chemotherapy
• Hematology: Hb>6.5 mmol/l; leukocytes>3.5x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l
• Renal function: serum creatinine <= 1.25 ULN and creatinine clearance > 60 ml/min (measured, or calculated by Cockcroft and Gault formula)
• Liver function: total bilirubin <1.5x ULN, Alk.phosph. and ASAT/ALAT <= 3x ULN
• Registration within 20 working days after gastroscopy
• Start treatment within 10 working days after registration
• Written informed consent
Exclusion criteria
• Distant metastasis; i.e. lymph node metastasis that are encompassed in the radiation portals are acceptable
• Suspected lymph nodes below the renal arteries
• Inoperable patients; due to technical surgery-related aspects or general condition (ASA III or IV)
• Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri. In case of other malignancies, the patients has to be disease-free for * 5 years to be eligible
• Previous radiotherapy involving the planned treatment field or compromising bone marrow reserve
• Previous chemotherapy except adjuvant chemotherapy for e.g. breast or coloncarcinoma, if * 5 years before
• Uncontrolled (bacterial) infections
• Significant non-malignant disease which in the opinion of the study coordinators is incompatible with the protocol
• Neurotoxicity > CTC grade 1
• Pregnancy or breast feeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004818-14-NL |
| CCMO | NL19010.031.07 |