Rectal NeoplasmsPhase 3NCT03415763
Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
A Phase 3 study testing Capecitabine and mFOLFOX6 or CAPOX in people with Rectal Neoplasms, run by LI XIN-XIANG at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Capecitabine and mFOLFOX6 or CAPOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2018to Dec 2025
- 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
- The lesion must be within 12 cm of the anus as measured by endoscopy
- Histologically confirmed diagnosis of rectal carcinoma
- CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs
- Without multiple primary cancer
- Sufficient organ function
- Able to provide written informed consent
Who cannot join
- Younger than 18 years or older than 75 years
- Synchronous or metachronous malignancy within 5 years.
- Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- Patients with a history of pelvic irradiation.
- ASA grade IV or V.
- Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding.
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- Severe mental illness.
- Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
- Patients who received steroid therapy within one month.
- Patients or family members misunderstand the conditions and goals of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xinxiang Li, MD,PhD, 86-13918176716, lxx1149@163.com
Qingguo Li, MD,PhD, 86-18918298120, 13111230016@fudan.edu.cn
About this study
Official title: Efficacy of Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Pathology-oriented, Prospective, Multicenter, Randomized, Open-label, Parallel Group Clinical Trial
The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.
Read the detailed description
Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
- Conditions
- Rectal Neoplasms
- Being tested
- Capecitabine, mFOLFOX6 or CAPOX
- Keywords
- Rectal Neoplasms, Adjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
mFOLFOX6 or CAPOXDrug
Also called 5-Fu-leucovorin-oxaliplatin or xeloda-oxaliplatin
According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Observation for patients with pathological complete response or yp stage I(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil) |
| 5-fluorouracil | Experimental | Capecitabine for patients with pathological complete response or yp stage I Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil ) Receives: Drug: Capecitabine |
| 5-fluorouracil alone | Experimental | 5-fluorouracil alone for patients with yp stage II or III Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone) Receives: Drug: Capecitabine |
| mFOLFOX6 or CAPOX | Experimental | Oxaliplatin combined with 5-fluorouracil for patients with yp stage II or III mFOLFOX6 (leucovorin 400 mg/m2 as a 2-hour infusion, and the concurrent administration of oxaliplatin 85 mg/m2 as a 2-hour infusion, followed by a bolus of 5-FU 400 mg/m2 within 15 min and 46-hour infusion of 5-FU 2400 mg/m2 on day 1 every 2 weeks), three cycles or CAPOX (oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, followed by capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks), three cycles( According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone) Receives: Drug: mFOLFOX6 or CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Calculated from the date of surgery to the date of recurrence
Measured: 3-year
Secondary outcomes (5)
Overall survival
Calculated from the date of diagnosis to the date of death from any cause
Measured: 3-year, 5-year
Disease free survival
Calculated from the date of surgery to the date of recurrence
Measured: 5-year
The rate of local recurrence
The ratio of the number of local recurrence to the total patients
Measured: 3-year
The rate of adverse events resulted from chemotherapy
The ratio of the number of patients experienced adverse events to the total patients
Measured: 3-year
The quality of life postoperatively
The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Measured: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start5 Nov 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (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 Rectal NeoplasmsStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 764 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI XIN-XIANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LI XIN-XIANG, Fudan University
- Investigators
- Xinxiang Li, MD,PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415763
- Sponsor's protocol ID
- Fudan AC
- Status last verified
- Nov 2018
- First submitted
- 17 Jan 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Q, Luo D, Zhu J, Yang L, Liu Q, Ma Y, Liang L, Cai S, Zhang Z, Li X; ACRNaCT study group. ACRNaCT trial protocol: efficacy of adjuvant chemotherapy in patients with clinical T3b/T4, N+ rectal Cancer undergoing Neoadjuvant Chemoradiotherapy: a pathology-oriented, prospective, multicenter, randomized, open-label, parallel group clinical trial. BMC Cancer. 2019 Nov 15;19(1):1117. doi: 10.1186/s12885-019-6289-6.
PubMed 31729964
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Pathology-oriented, Prospective, Multicenter, Randomized, Open-label, Parallel Group Clinical Trial
- ClinicalTrials.gov ID
- NCT03415763
- Acronym / sponsor ID
- Fudan AC
- Conditions
- Rectal Neoplasms
- Keywords
- Rectal Neoplasms, Adjuvant Chemotherapy, Neoadjuvant Chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 764 participants (estimated)
- Lead sponsor
- LI XIN-XIANGUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jan 2018 (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 evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.
Detailed description
Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Observation for patients with pathological complete response or yp stage I(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil) |
| 5-fluorouracil | Experimental | Drug: CapecitabineCapecitabine for patients with pathological complete response or yp stage I Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil ) |
| 5-fluorouracil alone | Experimental | Drug: Capecitabine5-fluorouracil alone for patients with yp stage II or III Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone) |
| mFOLFOX6 or CAPOX | Experimental | Drug: mFOLFOX6 or CAPOXOxaliplatin combined with 5-fluorouracil for patients with yp stage II or III mFOLFOX6 (leucovorin 400 mg/m2 as a 2-hour infusion, and the concurrent administration of oxaliplatin 85 mg/m2 as a 2-hour infusion, followed by a bolus of 5-FU 400 mg/m2 within 15 min and 46-hour infusion of 5-FU 2400 mg/m2 on day 1 every 2 weeks), three cycles or CAPOX (oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, followed by capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks), three cycles( According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The lesion must be within 12 cm of the anus as measured by endoscopy
- Histologically confirmed diagnosis of rectal carcinoma
- CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs
- Without multiple primary cancer
- Sufficient organ function
Key exclusion criteria (10 listed)
- Younger than 18 years or older than 75 years
- Synchronous or metachronous malignancy within 5 years.
- Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- Patients with a history of pelvic irradiation.
- ASA grade IV or V.
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: XelodaAccording to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone. | Drug | 5-fluorouracil, 5-fluorouracil alone |
| mFOLFOX6 or CAPOXAlso: 5-Fu-leucovorin-oxaliplatin or xeloda-oxaliplatinAccording to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone. | Drug | mFOLFOX6 or CAPOX |
Primary outcome
Disease free survival
Time frame: 3-year
Calculated from the date of surgery to the date of recurrence
5 secondary outcomes
Overall survival
Time frame: 3-year, 5-year
Disease free survival
Time frame: 5-year
The rate of local recurrence
Time frame: 3-year
The rate of adverse events resulted from chemotherapy
Time frame: 3-year
The quality of life postoperatively
Time frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 31729964Li Q, Luo D, Zhu J, Yang L, Liu Q, Ma Y, Liang L, Cai S, Zhang Z, Li X; ACRNaCT study group. ACRNaCT trial protocol: efficacy of adjuvant chemotherapy in patients with clinical T3b/T4, N+ rectal Cancer undergoing Neoadjuvant Chemoradiotherapy: a pathology-oriented, prospective, multicenter, randomized, open-label, parallel group clinical trial. BMC Cancer. 2019 Nov 15;19(1):1117. doi: 10.1186/s12885-019-6289-6.
- 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.
Xinxiang Li, MD,PhD principal investigator
Fudan University
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 Capecitabine and mFOLFOX6 or CAPOX in people with Rectal Neoplasms, run by LI XIN-XIANG 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 6 inclusion and 10 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 Nov 2018. 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 Xinxiang Li, MD,PhD (86-13918176716, lxx1149@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 (time frame: 3-year). 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 NCT03415763, 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 6 Nov 2018.