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Rectal CancerPhase 3COPECNCT04922853

Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer

A Phase 3 study testing Capox chemotherapy in people with Rectal Cancer and Neoadjuvant Chemotherapy, run by West China Hospital at 4 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer, Neoadjuvant Chemotherapy
What is being tested?
Capox chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
4 sitesChina
Study dates
26 Aug 2021to 1 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Age: 18-75 years old; No gender limitation;
  • Patients diagnosed with low/intermediate risk stage II/III rectal cancer under MRI and transanal ultrasound,defined as: low:T3a-bN0-1M0, EMVI (±), MRF (-) (≥2mm); Middle-high rectal cancer: T3a-cN0-1M0, EMVI (±), MRF (-) (≥2mm); No more than 3 lymph nodes with short diameter over 8mm or highly suspected metastases; Patients with very low rectal cancer who met the above criteria and could achieve negative circumferential resection margin under ELAPE surgery could be included in the group
  • tumor located <=12cm from anal verge by colonoscopy or anal examination
  • no distant metastasis confirmed by CT examination;
  • rectal adenocarcinoma confirmed by pathology,
  • ECOG score: 0-1;
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  • Patients with primary rectal cancer who did not receive surgery (except palliative stomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy before enrollment;
  • Main organs function normally, that is, meet the following characteristics: ① Blood routine examination criteria should meet: Hb ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophils ≥ 1.5×109/L, PLT≥ 100×109/L. ② Biochemical tests should meet the following criteria: CREA and BIL ≤ 1.0 times upper limit of normal (ULN), ALT and AST≤ 2.5 times upper limit of normal (ULN), alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (TBIL) ≤1.5×UNL.
  • No history of allergy to platinum drugs when no 5-FU drugs are allergic;
  • Women of childbearing age must have had a pregnancy test (serum or urine) 7 days prior to enrolment, be negative, and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dosing. For men, surgical sterilization or consent to use an appropriate method of contraception during the trial or for 8 weeks after the last dosing;
  • Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and followed up.

Who cannot join

  • patients suspect to Lynch syndrome;
  • Patients showed distant metastasis during treatment;
  • Previously or coexisting malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • pregnant or breastfeeding women;
  • Patients with severe cardiovascular diseases and diabetes that is not easily controlled;
  • People with mental disorders;
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  • Severe infection;
  • sever renal disfunction;
  • History of gastrointestinal fistula, perforation, bleeding, or severe ulcer;
  • Allergic to 5-FU or platinum;
  • The presence of serious gastrointestinal diseases that affect the absorption of oral chemotherapeutic drugs; (12) Participants in additional clinical trials within 4 weeks prior to the start of treatment.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • the Third People'S Hospital of Chengdu

    Chengdu, Sichuan, 610000

  • West China Hospital

    Chengdu, Sichuan, 610000

  • The Third Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Genecast Biotechnology Co., Ltd

    Wuxi, Jiangsu, 214104

Other trials in China

About this study

Official title: Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer：a Prospective, Non-inferior, Randomized, Controlled Trial

To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer.

Read the detailed description

Neoadjuvant Chemotherapy alone has showed much benefit for low/ intermediate risk stage II/III rectal cancer which would be verified by the PROSPECT trial. However, the effect of the Neoadjuvant chemotherapy was heterogeneous in different patients. It's important to verify those chemo-resistant cases as early as possible. So that, this trial will compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer to explore whether those chemotherapeutic non-responders after 2 cycles Capox was non-inferior to those after 4 cycles chemotherapy.

Being tested
Capox chemotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capox chemotherapyDrug

    oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals

Study groups in NCT04922853
Study groupRoleWhat they receive
2 cycles groupExperimentalpatients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have TME operation after reevaluation and randomization.
Receives: Drug: Capox chemotherapy
4 cycles groupOtherpatients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have two more cycles chemotherapy and TME operation after reevaluation and randomization.
Receives: Drug: Capox chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathological Tumor Regression Grade evaluation

    pTRG

    Measured: 12 weeks

Secondary outcomes (5)

  1. rate of chemotherapeutic complication

    Measured: 12 weeks

  2. 3-year overall survival

    the cumulative overall survival rate of the patients(events defined as all caused death)

    Measured: 3 year after recruiting

  3. disease free survival

    the cumulative disease free survival rate of the patients(events defined as tumor recurrence at any sites)

    Measured: 3 year after recruiting

  4. cumulative distant recurrence rate

    cumulative recurrence rate of Rectal cancer after the radical surgery outside the pelvic cavity

    Measured: 3 year after recruiting

  5. cumulative local recurrence rate

    cumulative recurrence rate of Rectal cancer after the radical surgery within the pelvic cavity or in the wounds

    Measured: 3 year after recruiting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start26 Aug 2021
  3. Primary completion1 Oct 2024
  4. Study completion1 Dec 2027 (estimated)

Resources

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
554 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922853
Sponsor's protocol ID
RC-CT-2021
Acronym
COPEC
Status last verified
Jul 2025
First submitted
4 Jun 2021
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Shen Y, Shi W, Huang C, Gong X, Wei M, Meng W, Deng X, Wang Z; COPEC groups. Comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks: study protocol for a prospective, non-inferior, randomized control trial (COPEC trial). Trials. 2023 Jun 13;24(1):397. doi: 10.1186/s13063-023-07405-x.

    PubMed 37312165

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capox chemotherapy in people with Rectal Cancer and Neoadjuvant Chemotherapy, run by West China Hospital at 4 sites 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 11 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

pathological Tumor Regression Grade evaluation (time frame: 12 weeks). 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 NCT04922853, 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 Jul 2025.

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