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Rectal CancerNCT05338866

Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator

An observational study of Rectal Cancer, run by Sun Yat-sen University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The incidence rate of colorectal cancer is third in male tumors and second in female tumors. The newly diagnosed incidence of colorectal cancer is no less than 100 thousand in China, which poses a great threat to people's health and a heavy burden of public health. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer
What is being tested?
Magnetic resonance guided radiotherapy and Chemotherapy
How many people
58 participants
Where
1 siteChina
Study dates
1 Jan 2022to 31 Dec 2033
Phase
Observational
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with lower rectal cancer who refuse surgery for various reasons or are not suitable for surgery due to systemic diseases.

Who may be able to join

  • Histologically confirmed as rectal adenocarcinoma.
  • MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge.
  • The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive.
  • MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR.
  • No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy.
  • Age: 18 ~ 80 years old.
Show all 12Show fewer
  • ECOG score: 0-1.
  • Expected life: more than 3 years.
  • Hematology: WBC > 3 × 109/L; PLT>80 × 109/L; Hb>90g/L.
  • Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value.
  • Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min.
  • Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment.

Who cannot join

  • There are any conditions that make MRI impossible.
  • There are serious medical complications.
  • Uncontrolled infectious diseases, autoimmune diseases and mental diseases.
  • Any unstable condition or situation that may endanger patient safety and compliance.
  • Pregnant or lactating women who are fertile and do not take adequate contraceptive measures.
  • Refuse to sign informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using Magnetic Resonance Guided Radiotherapy Linear Accelerator：A Prospective Phase 2 Trial

The incidence rate of colorectal cancer is third in male tumors and second in female tumors. The newly diagnosed incidence of colorectal cancer is no less than 100 thousand in China, which poses a great threat to people's health and a heavy burden of public health. Preoperative neoadjuvant radiotherapy and chemotherapy combined with radical surgery is recommended for locally advanced rectal cancer. Low rectal cancer accounts for about one third of all rectal cancer cases. Due to the particularity of its location，surgical complications and postoperative patients need permanent colostomy (artificial anus) to solve the defecation problems, which has a serious impact on the patients' work and life. How to improve the quality of life of patients without reducing the survival rate has become an important topic in the treatment of low rectal cancer. Previous studies have shown that the prognosis of patients with pathological complete remission (pCR) after neoadjuvant chemoradiotherapy for rectal cancer is optimistic. The clinical efficacy of "observation and waiting" is good. The results of small sample exploratory clinical studies of radical radiotherapy and chemotherapy for low rectal cancer are satisfactory, and MR-linear accelerator can be used for precision radiotherapy for colorectal cancer.

This study is aimed to explore the efficacy and safety of radical radiotherapy boost for low rectal cancer by using magnetic resonance guided radiotherapy system, and further evaluate the impact of boost on the quality of life of patients.

Read the detailed description

It is a prospective phase II, non-randomized controlled designed clinical study. For the optimal design, 58 cases of low rectal adenocarcinoma without metastasis were divided into queue 1 and queue 2 according to the start time of boost. MR-linear accelerator was used for dose boost of the local tumor region to make it reaching the radical radiotherapy dose. At the same time, fluorouracil based chemotherapy was given according to stages.

The primary endpoint was 3-year progression free survival rate. The secondary end points were 3-year stoma free survival rate, 3-year local regeneration rate, 3-year disease-free survival rate, 3-year distant metastasis rate, 3-year overall survival rate, short term and long-term toxic and side effects, and patients' quality of life scale 1-3 years after treatment.

Conditions
Rectal Cancer
Being tested
Magnetic resonance guided radiotherapy, Chemotherapy
Keywords
Lower rectal cancer, Magnetic resonance imaging guided radiation therapy, High-dose radiotherapy, Toxic and side effects, Quality of life score
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Magnetic resonance guided radiotherapyRadiation

    Radical radiotherapy boosting for low rectal cancer through magnetic resonance guided radiotherapy linear accelerator.

  • ChemotherapyDrug

    Also called Capox, Capecitabine

    For patients with AJCC stage II and III and age < 72 years old, Capox ×6→capecitabine×2.

    Detailed usage: Oxaliplatin 130mg/m2 (reduced to 100mg/m2 during concurrent chemoradiotherapy), intravenous administration, d1. Capecitabine 1000mg / m2, twice a day, d1-14. Repeated every 3 weeks.

    For patients aged ≥ 72 years, or the competent physician judges that the patients cannot tolerate dual drug combined chemotherapy, capecitabine ×8 courses.

    For patients with AJCC stage I, capecitabine ×4 courses.

Study groups in NCT05338866
Study groupRoleWhat they receive
Cohort 1. Cohort 2A total of 6 courses of oxaliplatin plus capecitabine chemotherapy and 2 courses of capecitabine single drug chemotherapy were performed. Concurrent chemoradiotherapy starts at the second cycle. Cohort 1: For patients with low rectal cancer who refused surgery before the initial diagnosis and treatment, the first stage of radiotherapy used conventional linear accelerated radiotherapy, with doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. Subsequently, the second stage of radiotherapy boost was continued with MR linear accelerator, and the dose was GTV 16~20Gy/8~10f for 2 weeks. Cohort 2: For locally advanced low rectal cancer patients who did not achieve clinical complete remission 6-8 weeks after neoadjuvant radiochemotherapy and refused surgery, radiotherapy was given in the first stage at the doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. In the second stage, MR linear accelerator was used for radiotherapy boosting, and the dose was GTV 30Gy/15f for 3 weeks.
Receives: Radiation: Magnetic resonance guided radiotherapy; Drug: Chemotherapy

What is being measured

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

  1. 3-year progression free survival rate

    Percentage of survive patients with no disease progression or death after 3 years from enrollment.

    Measured: 3-year after enrollment

Secondary outcomes (7)

  1. 3-year stoma free survival rate

    Percentage of patients survive with no enterostomy after 3 years from enrollment.

    Measured: 3-year after enrollment

  2. 3-year local regeneration rate

    Percentage of patients with no local tumor regeneration after 3 years from enrollment.

    Measured: 3-year after enrollment

  3. 3-year disease-free survival rate

    The percentage of patients survive with no disease after 3 years from enrollment

    Measured: 3-year after enrollment

  4. 3-year distant metastasis rate

    The percentage of patients with distant metastasis.

    Measured: 3-year after enrollment

  5. 3-year overall survival rate

    The percentage of patients survive 3 years after enrollment

    Measured: 3-year after enrollment

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Acute and chronic toxic and side effects

    Measured: During treatment. 3-month, 6-month, 1-year, 3-year after treatment.

  7. Patients' quality of life scale

    Patients' quality of life scale

    Measured: Before and during treatment. 3-month, 6-month, 1-year, 3-year after enrollment.

Timeline

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

  1. First posted21 Apr 2022
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338866
Sponsor's protocol ID
2021-FXY-489
Status last verified
Nov 2023
First submitted
5 Apr 2022
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Study data can be shared after publication of the study results, upon request.

Publications

  • Wang Q, Zhang S, Zhou C, et al. Efficacy and safety of high dose radiotherapy for the treatment of locally advanced rectal cancer. International Journal of Radiation Oncology Biology Physics. 2020. 108(3): e644-e645

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PubMed 25651787

  • Glimelius B, Tiret E, Cervantes A, Arnold D; ESMO Guidelines Working Group. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi81-8. doi: 10.1093/annonc/mdt240. No abstract available.

    PubMed 24078665

  • Galandiuk S, Wieand HS, Moertel CG, Cha SS, Fitzgibbons RJ Jr, Pemberton JH, Wolff BG. Patterns of recurrence after curative resection of carcinoma of the colon and rectum. Surg Gynecol Obstet. 1992 Jan;174(1):27-32.

    PubMed 1729745

  • Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.

    PubMed 19269519

  • Heald RJ, Ryall R. Recurrent cancer after restorative resection of the rectum. Br Med J (Clin Res Ed). 1982 Mar 13;284(6318):826-7. doi: 10.1136/bmj.284.6318.826-e. No abstract available.

    PubMed 6802248

  • Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.

    PubMed 15496622

  • Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rodel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. doi: 10.1200/JCO.2011.40.1836. Epub 2012 Apr 23.

    PubMed 22529255

  • Roh MS, Colangelo LH, O'Connell MJ, Yothers G, Deutsch M, Allegra CJ, Kahlenberg MS, Baez-Diaz L, Ursiny CS, Petrelli NJ, Wolmark N. Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03. J Clin Oncol. 2009 Nov 1;27(31):5124-30. doi: 10.1200/JCO.2009.22.0467. Epub 2009 Sep 21.

    PubMed 19770376

  • Benson AB 3rd, Venook AP, Bekaii-Saab T, Chan E, Chen YJ, Cooper HS, Engstrom PF, Enzinger PC, Fenton MJ, Fuchs CS, Grem JL, Grothey A, Hochster HS, Hunt S, Kamel A, Kirilcuk N, Leong LA, Lin E, Messersmith WA, Mulcahy MF, Murphy JD, Nurkin S, Rohren E, Ryan DP, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Freedman-Cass D. Rectal Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Jun;13(6):719-28; quiz 728. doi: 10.6004/jnccn.2015.0087.

    PubMed 26085388

  • Sautter-Bihl ML, Hohenberger W, Fietkau R, Rodel C, Schmidberger H, Sauer R. Rectal cancer : when is the local recurrence risk low enough to refrain from the aim to prevent it? Strahlenther Onkol. 2013 Feb;189(2):105-10. doi: 10.1007/s00066-012-0299-5.

    PubMed 23299826

  • Feddern ML, Emmertsen KJ, Laurberg S. Life with a stoma after curative resection for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2015 Nov;17(11):1011-7. doi: 10.1111/codi.13041.

    PubMed 26112651

  • Konanz J, Herrle F, Weiss C, Post S, Kienle P. Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer--a matched-pair analysis. Int J Colorectal Dis. 2013 May;28(5):679-88. doi: 10.1007/s00384-013-1683-z. Epub 2013 Apr 10.

    PubMed 23571868

  • Lim L, Chao M, Shapiro J, Millar JL, Kipp D, Rezo A, Fong A, Jones IT, McLaughlin S, Gibbs P. Long-term outcomes of patients with localized rectal cancer treated with chemoradiation or radiotherapy alone because of medical inoperability or patient refusal. Dis Colon Rectum. 2007 Dec;50(12):2032-9. doi: 10.1007/s10350-007-9062-x. Epub 2007 Sep 26.

    PubMed 17896138

  • Gao YH, Lin JZ, An X, Luo JL, Cai MY, Cai PQ, Kong LH, Liu GC, Tang JH, Chen G, Pan ZZ, Ding PR. Neoadjuvant sandwich treatment with oxaliplatin and capecitabine administered prior to, concurrently with, and following radiation therapy in locally advanced rectal cancer: a prospective phase 2 trial. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1153-60. doi: 10.1016/j.ijrobp.2014.07.021. Epub 2014 Oct 13.

    PubMed 25442042

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer, 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 12 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: enrolling by invitation, as of the sponsor's last update on 22 Nov 2023. 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.

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?

3-year progression free survival rate (time frame: 3-year after enrollment). 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 NCT05338866, which also lists 24 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 22 Nov 2023.

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