Stomach CancerEarly Phase 1NCT00215514
Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma
A Early Phase 1 study testing Epirubicin, Cisplatin and 5-Fluorouracil (5-FU) in people with Stomach Cancer and Gastric Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer, Gastric Cancer, Gastro-esophageal Junction Cancer
- What is being tested?
- Epirubicin, Cisplatin and 5-Fluorouracil (5-FU)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2000to Jul 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
- Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected.
- The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging.
- Treatment must begin between day 20 and day 56 after the gastrectomy.
- ECOG performance status of 0,1 or 2
- ANC > 1,500/ul and platelet count >100,000/ul
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- Serum creatinine < 1.5mg/dl
- Total bilirubin < 2.0 mg/dl and AST < 3 x ULN
- Estimated caloric intake of 1500K calories per day or greater
Who cannot join
- Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease
- Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years
- Previous chemotherapy or radiotherapy
- Active infectious process
- Pregnant or lactating women
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- Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease
- Uncontrolled serious medical or psychiatric condition
- Grade 2 or greater peripheral neuropathy at baseline
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.
Read the detailed description
- Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment. 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump (CADD pump) for 21 days. This cycle of chemotherapy will take 21 days (3 weeks). Once it is complete there will be one week without therapy.
- Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy, 5-fluorouracil and radiation. The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located. The radiation therapy will be given five days a week for a total of five weeks. During these five weeks patients will receive 5-fluorouracil continuously by CADD pump.
- After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle.
- The following tests and procedures will be performed: physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly; blood tests every week during chemotherapy and chemoradiation; CT scans and chest x-rays done before therapy, at the end of therapy, and yearly for 2 years; noninvasive testing to evaluate kidney function before starting the study.
- The program of chemotherapy and radiation therapy will last approximately 30 weeks. After all treatment is completed, patients will return for physical examinations and blood tests every 3 months for 3 years; then every 6 months for 2 years.
- Being tested
- Epirubicin, Cisplatin, 5-Fluorouracil (5-FU), Radiation
- Keywords
- adjuvant chemoradiation, GE junction, epirubicin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
CisplatinDrug
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
5-Fluorouracil (5-FU)Drug
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
RadiationProcedure or surgery
Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).
| Study group | Role | What they receive |
|---|---|---|
| ECF followed by 5-FU/RT followed by ECF | Experimental | Not described Receives: Drug: Epirubicin; Drug: Cisplatin; Drug: 5-Fluorouracil (5-FU); Procedure: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2000
- Primary completionNov 2003
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Charles S. Fuchs, MD, Dana-Farber Cancer Institute
- Investigators
- Charles S. Fuchs, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215514
- Sponsor's protocol ID
- 00-165
- Status last verified
- Jul 2014
- First submitted
- 20 Sep 2005
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00215514
- Acronym / sponsor ID
- 00-165
- Keywords
- adjuvant chemoradiation, GE junction, epirubicin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Sep 2000
- Primary completion
- Nov 2003 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.
Detailed description
- Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment. 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump (CADD pump) for 21 days. This cycle of chemotherapy will take 21 days (3 weeks). Once it is complete there will be one week without therapy.
- Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy, 5-fluorouracil and radiation. The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located. The radiation therapy will be given five days a week for a total of five weeks. During these five weeks patients will receive 5-fluorouracil continuously by CADD pump.
- After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle.
- The following tests and procedures will be performed: physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly; blood tests every week during chemotherapy and chemoradiation; CT scans and chest x-rays done before therapy, at the end of therapy, and yearly for 2 years; noninvasive testing to evaluate kidney function before starting the study.
- The program of chemotherapy and radiation therapy will last approximately 30 weeks. After all treatment is completed, patients will return for physical examinations and blood tests every 3 months for 3 years; then every 6 months for 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECF followed by 5-FU/RT followed by ECF | Experimental | Drug: Epirubicin, Drug: Cisplatin, Drug: 5-Fluorouracil (5-FU), Procedure: Radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
- Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected.
- The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging.
- Treatment must begin between day 20 and day 56 after the gastrectomy.
- ECOG performance status of 0,1 or 2
Key exclusion criteria (9 listed)
- Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease
- Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years
- Previous chemotherapy or radiotherapy
- Active infectious process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpirubicinEpirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21). | Drug | ECF followed by 5-FU/RT followed by ECF |
| CisplatinEpirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21). | Drug | ECF followed by 5-FU/RT followed by ECF |
| 5-Fluorouracil (5-FU)Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21). | Drug | ECF followed by 5-FU/RT followed by ECF |
| RadiationEpirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> One-week rest --> External Beam Radiation Therapy plus 5-FU CI --> Four-week rest --> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21). | Procedure or surgery | ECF followed by 5-FU/RT followed by ECF |
Primary outcome
To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S. Fuchs, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Epirubicin, Cisplatin and 5-Fluorouracil (5-FU) in people with Stomach Cancer and Gastric Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.