Adjuvant ChemotherapyPhase 3EPAC1NCT03199989
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
A Phase 3 study testing CapeOX（Capecitabine+Oxaliplatin） and Observation in people with Adjuvant Chemotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adjuvant Chemotherapy
- What is being tested?
- CapeOX（Capecitabine+Oxaliplatin） and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,254 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Jul 2024
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 75 years;
- pathologically confirmed adenocarcinoma of the colon
- after curative resection pathological stage was T3-4N0M0;
- with at least one of the following factors:
- T4 staging
- lymph nodes number less than 12
Show all 15Show fewer
- poor differentiation (except MSI-H)
- LVI or PNI
- obstruction or perforation
- Elevated preoperative serum CEA
- ECOG Performance status 0-1
- no evidence of distant metastases
- no preoperative chemotherapy or chemoradiation therapy
- ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 xULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Who cannot join
- combined with other cancer
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who have received preoperative chemotherapy or chemoradiotherapy.
- Patients with a history of a prior malignancy within the past 5 years.
- Women who are pregnant or breast-feeding.
- patients may not complete the whole schedule of chemotherapy
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing cancer hospital
Beijing
Pengju Chen, M.D.
Aiwen Wu, M.D.
About this study
The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.
Read the detailed description
The most controversial of adjuvant chemotherapy for colon cancer is whether stage II colon cancer should receive adjuvant chemotherapy or not. Because of the absolute little benefit of adjuvant chemotherapy after curative resection of stage II colon cancer，NCCN and ESMO guidelines do not recommend routine adjuvant chemotherapy for patients with stage II colon cancer unless combined with high risk factors.
Currently，most studies about stage II colon cancer with high risk factors were retrospective. Some suggested that patients with stage II colon cancer can benefit from adjuvant chemotherapy, however, more got the negative conclusions.
The study was designed as a multicenter, prospective, randomized, controlled trial.Patients who agreed to participate in the study would be randomly assigned to a treatment group of adjuvant chemotherapy or observation with 50% chance by a central randomization system determined by the computer program.
After a follow up of at least 3 years, the disease free survival of the two groups will be compared.
- Conditions
- Adjuvant Chemotherapy
- Being tested
- CapeOX（Capecitabine+Oxaliplatin）, Observation
- Keywords
- colon cancer, adjuvant chemotherapy, high risk
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapeOX（Capecitabine+Oxaliplatin）Drug
Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
ObservationOther
Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
| Study group | Role | What they receive |
|---|---|---|
| adjuvant chemotherapy group | Active comparator | patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines Receives: Drug: CapeOX（Capecitabine+Oxaliplatin） |
| observation group | Experimental | patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Disease free survival was defined as the duration after local recurrence or metastasis were found after surgery. Metastasis of any distant organs such as liver, lung, ovary，bone and peritoneum were defined by CT.
Measured: At least 3 years after the last patient enrolled
Secondary outcomes (4)
3-year overall survival
Overall survival was defined as the duration from randomization to death from any cause
Measured: At least 3 years after the last patient enrolled
Rate of metastasis
Rate of metastasis in different groups
Measured: At least 3 years after the last patient enrolled
Relationship between high risk factors and survival
All the high risk factors enrolled in this study will be analyzed one by one to investigate the relationship between high risk factors and survival.
Measured: At least 3 years after the last patient enrolled
Major adverse events
Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: At least 1 years after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Jun 2017
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjuvant ChemotherapyStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospertive randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 1,254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiwen Wu, Peking University Cancer Hospital & Institute
- Investigators
- Aiwen Wu, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199989
- Sponsor's protocol ID
- PKUCH-C01
- Acronym
- EPAC1
- Status last verified
- Mar 2020
- First submitted
- 4 Jun 2017
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
- ClinicalTrials.gov ID
- NCT03199989
- Acronym / sponsor ID
- EPAC1 / PKUCH-C01
- Conditions
- Adjuvant Chemotherapy
- Keywords
- colon cancer, adjuvant chemotherapy, high risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,254 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University People's Hospital
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 27 Jun 2017 (actual)
- 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 purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.
Detailed description
The most controversial of adjuvant chemotherapy for colon cancer is whether stage II colon cancer should receive adjuvant chemotherapy or not. Because of the absolute little benefit of adjuvant chemotherapy after curative resection of stage II colon cancer，NCCN and ESMO guidelines do not recommend routine adjuvant chemotherapy for patients with stage II colon cancer unless combined with high risk factors.
Currently，most studies about stage II colon cancer with high risk factors were retrospective. Some suggested that patients with stage II colon cancer can benefit from adjuvant chemotherapy, however, more got the negative conclusions.
The study was designed as a multicenter, prospective, randomized, controlled trial.Patients who agreed to participate in the study would be randomly assigned to a treatment group of adjuvant chemotherapy or observation with 50% chance by a central randomization system determined by the computer program.
After a follow up of at least 3 years, the disease free survival of the two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospertive randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| adjuvant chemotherapy group | Active comparator | Drug: CapeOX（Capecitabine+Oxaliplatin）patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines |
| observation group | Experimental | Other: Observationpatients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- aged 18 to 75 years;
- pathologically confirmed adenocarcinoma of the colon
- after curative resection pathological stage was T3-4N0M0;
- with at least one of the following factors:
- ECOG Performance status 0-1
Key exclusion criteria (7 listed)
- combined with other cancer
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who have received preoperative chemotherapy or chemoradiotherapy.
- Patients with a history of a prior malignancy within the past 5 years.
- Women who are pregnant or breast-feeding.
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 |
|---|---|---|
| CapeOX（Capecitabine+Oxaliplatin）Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months | Drug | adjuvant chemotherapy group |
| ObservationPatients enrolled in the observation group would not receive any chemotherapy drugs just for observation | Other | observation group |
Primary outcome
3-year disease free survival
Time frame: At least 3 years after the last patient enrolled
Disease free survival was defined as the duration after local recurrence or metastasis were found after surgery. Metastasis of any distant organs such as liver, lung, ovary，bone and peritoneum were defined by CT.
4 secondary outcomes
3-year overall survival
Time frame: At least 3 years after the last patient enrolled
Rate of metastasis
Time frame: At least 3 years after the last patient enrolled
Relationship between high risk factors and survival
Time frame: At least 3 years after the last patient enrolled
Major adverse events
Time frame: At least 1 years after the last patient enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Aiwen Wu, M.D. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CapeOX（Capecitabine+Oxaliplatin） and Observation in people with Adjuvant Chemotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
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 15 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengju Chen, M.D. (+8613811403082, pengjuchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival (time frame: At least 3 years after the last patient enrolled). 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 6 Mar 2020.