Colorectal NeoplasmsPhase 2CAMCONCT01880658
Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer
A Phase 2 study testing Capecitabine in people with Colorectal Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to May 2019
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Adenocarcinoma of the colon or rectum
- Age:18-80 years old
- Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected)
- Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months 5.15 days prior recruit, meet the following criteria:
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
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- Platelet count ≥ 100,000/mm^3
- Hepatic
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- Aspartate transaminase ≤ 2.5 times ULN
- Alanine transaminase ≤ 2.5 times ULN
- No hepatic disease that would preclude study treatment or follow-up
- No uncontrolled coagulopathy
- Renal
- Creatinine clearance > 50 mL/min
- No renal disease that would preclude study treatment or follow-up
- 6.The ECOG scores: 0～1
Who cannot join
- Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- Synchronous cancer of other site
- Hypersensitivity to capecitabine
- No More than 4 weeks since prior participation in any investigational drug study
- Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
- History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
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- Uncontrolled hypertension
- Cardiovascular disease that would preclude study treatment or follow-up
- Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
- Pregnant or nursing, Fertile patients do not use effective contraception
- Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
- No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, MD, 008613925106525, 13925106525@163.com
Yanhong Deng, MD
About this study
Official title: Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown.
PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy followed by maintenance therapy with capecitabine to see the efficacy and safety, then to investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV colorectal cancer.
Read the detailed description
OBJECTIVES Primary evaluate the disease free survival rate of three years in patients with stage IIIC or resectable stage IV colorectal cancer treated with maintenance capecitabine.
Secondary
- Evaluate the over all survival time in patients treated with these regimens.
- Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
- Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
- Determine the toxic effects of maintenance regimens in these patients.
- Determine the convenience of care in patients treated with maintenance regimens.
OUTLINE: This is a single arm, single-enter study. Patients are receiving therapies as below.
Patients undergo R0-R1 resection and receive adjuvant chemotherapy oxaliplatin with fluorouracil (5FU) and folinic acid（FOLFOX）or oxaliplatin with oxaliplatin with capecitabine(capox) for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance.
Quality of life is assessed at completion of adjuvant treatment, at completion of maintenance chemotherapy , and at 1 year after maintenance chemotherapy.
After completion of adjuvant treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Eligibility Ages Eligible for Study: 18-80 Years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No
- Conditions
- Colorectal Neoplasms
- Being tested
- Capecitabine
- Keywords
- Maintenance therapy, Capecitabine, Adjuvant chemotherapy, Post-operation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Patients undergo R0-R1 resection and receive adjuvant chemotherapy FOLFOX or Capox for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival rate(DFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Measured: 36 months
Secondary outcomes (1)
Over all survival,genetic patterns, quality of life, toxic effects, convenience
- Evaluate the over all survival time in patients treated with these regimens.
- Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
- Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
- Determine the toxic effects of maintenance regimens in these patients.
- Determine the convenience of care in patients treated with maintenance regimens.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2016 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Yanhong Deng, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880658
- Sponsor's protocol ID
- GIHSYSU03
- Acronym
- CAMCO
- Status last verified
- Jul 2013
- First submitted
- 5 Jun 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ling J, Lin Z, Shi L, Lin Y, Liu X, Lin J, Li J, Zhang J, Hu H, Cai Y, Deng Y. Capecitabine maintenance therapy in metastatic colorectal cancer patients with no evidence of disease: CAMCO trial. Future Oncol. 2023 Sep;19(30):2045-2054. doi: 10.2217/fon-2023-0149. Epub 2023 Oct 10.
PubMed 37814832
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
- ClinicalTrials.gov ID
- NCT01880658
- Acronym / sponsor ID
- CAMCO / GIHSYSU03
- Conditions
- Colorectal Neoplasms
- Keywords
- Maintenance therapy, Capecitabine, Adjuvant chemotherapy, Post-operation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 19 Jun 2013 (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.
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown.
PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy followed by maintenance therapy with capecitabine to see the efficacy and safety, then to investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV colorectal cancer.
Detailed description
OBJECTIVES Primary evaluate the disease free survival rate of three years in patients with stage IIIC or resectable stage IV colorectal cancer treated with maintenance capecitabine.
Secondary
- Evaluate the over all survival time in patients treated with these regimens.
- Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
- Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
- Determine the toxic effects of maintenance regimens in these patients.
- Determine the convenience of care in patients treated with maintenance regimens.
OUTLINE: This is a single arm, single-enter study. Patients are receiving therapies as below.
Patients undergo R0-R1 resection and receive adjuvant chemotherapy oxaliplatin with fluorouracil (5FU) and folinic acid（FOLFOX）or oxaliplatin with oxaliplatin with capecitabine(capox) for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance.
Quality of life is assessed at completion of adjuvant treatment, at completion of maintenance chemotherapy , and at 1 year after maintenance chemotherapy.
After completion of adjuvant treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Eligibility Ages Eligible for Study: 18-80 Years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabinePatients undergo R0-R1 resection and receive adjuvant chemotherapy FOLFOX or Capox for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of Adenocarcinoma of the colon or rectum
- Age:18-80 years old
- Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected)
- Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months 5.15 days prior recruit, meet the following criteria:
- 6.The ECOG scores: 0～1
Key exclusion criteria (12 listed)
- Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- Synchronous cancer of other site
- Hypersensitivity to capecitabine
- No More than 4 weeks since prior participation in any investigational drug study
- Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
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 |
|---|---|---|
| CapecitabineAlso: XelodaCapecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year) | Drug | Capecitabine |
Primary outcome
Disease-free Survival rate(DFS)
Time frame: 36 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
1 secondary outcome
Over all survival,genetic patterns, quality of life, toxic effects, convenience
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Derived from this study: PubMed 37814832Ling J, Lin Z, Shi L, Lin Y, Liu X, Lin J, Li J, Zhang J, Hu H, Cai Y, Deng Y. Capecitabine maintenance therapy in metastatic colorectal cancer patients with no evidence of disease: CAMCO trial. Future Oncol. 2023 Sep;19(30):2045-2054. doi: 10.2217/fon-2023-0149. Epub 2023 Oct 10.
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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.
Yanhong Deng, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Colorectal Neoplasms, run by Sun Yat-sen University 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 18 inclusion and 12 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 11 Feb 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yanhong Deng, MD (008613925106525, 13925106525@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival rate(DFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880658, which also lists 1 linked publication.
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 11 Feb 2014.