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Rectal Cancer, AdenocarcinomaPhase 3NCT03038217

Investigation of the Value of ctDNA in Diagnosis, Treatment, and Surveillance of Surgically Resectable Colorectal Cancer

A Phase 3 study testing Capecitabine +/- Oxaliplatin, local resection and radical resection in people with Rectal Cancer, Adenocarcinoma and Neoadjuvant Chemoradiation, run by Peking Union Medical College Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical specimens, and observation of patients… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Capecitabine +/- Oxaliplatin, local resection and radical resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Feb 2017to Dec 2021
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

  • Patients aged 18 to 75 years old.
  • Patients with surgically resectable colorectal cancer, while without distal metastasis of the disease.
  • Patients with ASA physical status scroe of I to III.
  • Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.
  • Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.

Who cannot join

  • Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).
  • Patient is pregnant or lactating.
  • Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.
  • Patient is participating in any other clinical trials within 30 days prior to screening.
  • Patient has severe mental illness.
  • Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.

Trial locations and contacts

No sites are listed yet.

Jiaolin Zhou, MD contact

8613910136704

conniezhjl@yahoo.com

About this study

Official title: Investigation of the Value of ctDNA Analysis in the Diagnosis, Treatment, and Surveillance of Patients With Surgically Resectable Colorectal Cancer

In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical specimens, and observation of patients undergoing radical resection of the tumor with or without adjuvant chemo- and/or radiotherapy.

Read the detailed description

A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of the combined modality treatment for colorectal cancer and the patients' long-term prognosis.

Research objects: patients with surgically resectable colorectal cancer. After giving fully informed consent, the prospective participants will undergo the classical combined modality treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, (post-NCRT for NCRT patients), postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The 3 year disease free survival (3y-DFS) will be the primary end-point.

Being tested
Capecitabine +/- Oxaliplatin, local resection, radical resection, No adjuvant chemotherapy
Keywords
rectal cancer, neoajuvant chemoradiation, circulating tumor DNA
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Capecitabine +/- OxaliplatinDrug

    Patients in ACT group will undergo postoperative adjuvant chemotherapy with single agent Capecitabine regimen or combined Capecitabine +Oxaliplatin regimen.

  • local resectionProcedure or surgery

    Also called LR

    Patients in the LR group will undergo local resection of the T1-2N0 rectal carcinoma

  • radical resectionProcedure or surgery

    Also called RR

    Patients in the RR group will undergo radical resection of the T1-2N0 rectal carcinoma

  • No adjuvant chemotherapyOther

    Patients in Non-ACT group will not undergo postoperative adjuvant chemotherapy.

Study groups in NCT03038217
Study groupRoleWhat they receive
ACT groupExperimentalGroup of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin.
Receives: Drug: Capecitabine +/- Oxaliplatin
Non-ACT groupExperimentalGroup of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy.
Receives: Other: No adjuvant chemotherapy
LR groupExperimentalGroup of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR)
Receives: Procedure: local resection
RR groupExperimentalGroup of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)
Receives: Procedure: radical resection

What is being measured

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

  1. 5y DFS

    The 5-year disease free survival rate of the patients.

    Measured: 5 years

  2. 5y LR

    The 5-year local recurrence rate of the patients.

    Measured: 5 years

  3. 5y OS

    The 5-year overall survival rate of the patients.

    Measured: 5 years

Secondary outcomes (3)

  1. Changes of ctDNA level after surgery

    Changes of patients' ctDNA level after undergoing surgical resection of the tumor.

    Measured: 1 month

  2. Changes of ctDNA level after adjuvant therapy

    Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy).

    Measured: 6 months

  3. Changes of ctDNA level when disease recurs

    Changes of patients' ctDNA level after disease recurrence happens

    Measured: 5 year

Timeline

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

  1. First posted31 Jan 2017 (estimated)
  2. Study startFeb 2017 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2021 (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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038217
Sponsor's protocol ID
PekingUMCH-Colorectal Surgery
Status last verified
Feb 2017
First submitted
20 Dec 2016
Last updated
3 Feb 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.

    PubMed 25654990

  • Stroun M, Anker P, Maurice P, Lyautey J, Lederrey C, Beljanski M. Neoplastic characteristics of the DNA found in the plasma of cancer patients. Oncology. 1989;46(5):318-22. doi: 10.1159/000226740.

    PubMed 2779946

  • Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.

    PubMed 27384348

  • Zhou J, Chang L, Guan Y, Yang L, Xia X, Cui L, Yi X, Lin G. Application of Circulating Tumor DNA as a Non-Invasive Tool for Monitoring the Progression of Colorectal Cancer. PLoS One. 2016 Jul 26;11(7):e0159708. doi: 10.1371/journal.pone.0159708. eCollection 2016.

    PubMed 27459628

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine +/- Oxaliplatin, local resection and radical resection in people with Rectal Cancer, Adenocarcinoma and Neoadjuvant Chemoradiation, run by Peking Union Medical College Hospital.

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 5 inclusion and 6 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

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 Jiaolin Zhou, MD (8613910136704, conniezhjl@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5y DFS (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT03038217, which also lists 4 linked publications.

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 3 Feb 2017.

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