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AzTrials

Rectal CancerPhase 2NCT03666442

Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

A Phase 2 study testing XELOX in people with Rectal Cancer, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
XELOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteChina
Study dates
1 Jun 2018to 1 Jan 2022
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • .endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
  • .primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
  • .age from 20-75;
  • .with informed consent;

Who cannot join

  • .refuse the further treatment after recruiting;
  • .diagnosis of peritoneal metastasis in the surgery;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guoxue Road 37#,West China Hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer

Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.

Read the detailed description

Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.

Conditions
Rectal Cancer
Being tested
XELOX
Keywords
rectal cancer；, neoadjuvant 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.

  • XELOXDrug

    Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks

Study groups in NCT03666442
Study groupRoleWhat they receive
chemotherapy groupExperimentalpatients receive 4 cycles of Xelox
Receives: Drug: XELOX

What is being measured

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

  1. tumor volume

    tumor volume measured by MRI

    Measured: At the end of Cycle 2 (each cycle is 3 weeks)

  2. tumor area in endoscopy

    tumor area measured in endoscopy

    Measured: At the end of Cycle 2 (each cycle is 3 weeks)

  3. tumor volume

    tumor volume measured by MRI

    Measured: At the end of Cycle 4 (each cycle is 3 weeks)

  4. tumor area in endoscopy

    tumor area measured in endoscopy

    Measured: At the end of Cycle 4 (each cycle is 3 weeks)

Secondary outcomes (4)

  1. blood DNA test

    blood DNA test

    Measured: At the end of Cycle 2 (each cycle is 3 weeks)

  2. blood DNA test

    blood DNA test

    Measured: At the end of Cycle 4 (each cycle is 3 weeks)

  3. tumor thickness in TRUS

    tumor thickness in TRUS

    Measured: At the end of Cycle 4 (each cycle is 3 weeks)

  4. tumor thickness in TRUS

    tumor thickness in TRUS

    Measured: At the end of Cycle 2 (each cycle is 3 weeks)

Timeline

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

  1. First posted11 Sep 2018
  2. Study start1 Jun 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2022

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
a group of patients receive 4 cycle of Xelox chemotherapy, MRI,TRUS, DE,endoscopy, blood DNA test,before, between and after chemotherapy was compared to detect the effect of chemotherapy in 2 cycles.
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03666442
Sponsor's protocol ID
RC-CT-2018
Status last verified
Apr 2022
First submitted
18 Aug 2018
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schrag D, Weiser MR, Goodman KA, Gonen M, Hollywood E, Cercek A, Reidy-Lagunes DL, Gollub MJ, Shia J, Guillem JG, Temple LK, Paty PB, Saltz LB. Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial. J Clin Oncol. 2014 Feb 20;32(6):513-8. doi: 10.1200/JCO.2013.51.7904. Epub 2014 Jan 13.

    PubMed 24419115

  • Sclafani F, Cunningham D. Neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer. Future Oncol. 2014 Nov;10(14):2243-57. doi: 10.2217/fon.14.127.

    PubMed 25471037

  • Birlik B, Obuz F, Elibol FD, Celik AO, Sokmen S, Terzi C, Sagol O, Sarioglu S, Gorken I, Oztop I. Diffusion-weighted MRI and MR- volumetry--in the evaluation of tumor response after preoperative chemoradiotherapy in patients with locally advanced rectal cancer. Magn Reson Imaging. 2015 Feb;33(2):201-12. doi: 10.1016/j.mri.2014.08.041. Epub 2014 Nov 13.

    PubMed 25460330

  • Zhang J, Cai Y, Hu H, Lan P, Wang L, Huang M, Kang L, Wu X, Wang H, Ling J, Xiao J, Wang J, Deng Y. Nomogram basing pre-treatment parameters predicting early response for locally advanced rectal cancer with neoadjuvant chemotherapy alone: a subgroup efficacy analysis of FOWARC study. Oncotarget. 2016 Jan 26;7(4):5053-62. doi: 10.18632/oncotarget.6469.

    PubMed 26646794

  • Koike J, Funahashi K, Yoshimatsu K, Yokomizo H, Kan H, Yamada T, Ishida H, Ishibashi K, Saida Y, Enomoto T, Katsumata K, Hisada M, Hasegawa H, Koda K, Ochiai T, Sakamoto K, Shiokawa H, Ogawa S, Itabashi M, Kameoka S. Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer: the FACT trial. Cancer Chemother Pharmacol. 2017 Mar;79(3):519-525. doi: 10.1007/s00280-017-3243-7. Epub 2017 Feb 1.

    PubMed 28150022

  • Patel UB, Brown G, Machado I, Santos-Cores J, Pericay C, Ballesteros E, Salud A, Isabel-Gil M, Montagut C, Maurel J, Ramon-Ayuso J, Martin N, Estevan R, Fernandez-Martos C. MRI assessment and outcomes in patients receiving neoadjuvant chemotherapy only for primary rectal cancer: long-term results from the GEMCAD 0801 trial. Ann Oncol. 2017 Feb 1;28(2):344-353. doi: 10.1093/annonc/mdw616.

    PubMed 28426108

  • Chee CG, Kim YH, Lee KH, Lee YJ, Park JH, Lee HS, Ahn S, Kim B. CT texture analysis in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy: A potential imaging biomarker for treatment response and prognosis. PLoS One. 2017 Aug 10;12(8):e0182883. doi: 10.1371/journal.pone.0182883. eCollection 2017.

    PubMed 28797063

  • Battersby NJ, How P, Moran B, Stelzner S, West NP, Branagan G, Strassburg J, Quirke P, Tekkis P, Pedersen BG, Gudgeon M, Heald B, Brown G; MERCURY II Study Group. Prospective Validation of a Low Rectal Cancer Magnetic Resonance Imaging Staging System and Development of a Local Recurrence Risk Stratification Model: The MERCURY II Study. Ann Surg. 2016 Apr;263(4):751-60. doi: 10.1097/SLA.0000000000001193.

    PubMed 25822672

  • Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available.

    PubMed 28881920

  • Deng X, Wu Q, Bi L, Yu Y, Huang S, He D, Wu B, Gou H, Meng W, Qiu M, He Y, Wang Z. Early response to upfront neoadjuvant chemotherapy (CAPOX) alone in low- and intermediate-risk rectal cancer: a single-arm phase II trial. Br J Surg. 2021 Dec 17;109(1):121-128. doi: 10.1093/bjs/znab388.

    PubMed 34792107

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XELOX in people with Rectal Cancer, run by West China Hospital 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 29 Apr 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

tumor volume (time frame: At the end of Cycle 2 (each cycle is 3 weeks)). The study lists 4 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 NCT03666442, which also lists 10 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 29 Apr 2022.

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